Colon CancerNCT05128708
Combined Medial and Caudal Approach for Right Hemicolectomy
A study testing combined medial and caudal approach right hemicolectomy open and laparoscopic in people with Colon Cancer, run by Zagazig University at 1 site in Egypt.
Trial summary
Right sided hemicolectomy is the standard type of operation for cancers in the caecum, the ascending colon, proximal transverse colon.The aim of this study was to assess the safety and feasibility of combined medial and caudal approach in performing right hemicolectomy and to compare outcome between laparoscopic and… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- combined medial and caudal approach right hemicolectomy open and laparoscopic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Aug 2020to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed right colon cancer with colonoscopic biopsy.
- No invasion of the surrounding tissue.
- No distant metastasis except the liver.
Who cannot join
- Informed consent refusal
- Malignancy recurrence
- Distant metastasis except the liver.
- Locally advanced tumor.
- participants need emergent intervention e.g., intestinal obstruction or perforation.
- Contraindications specific for laparoscopy for laparoscopy cases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Feasibility of the Combined Medial and Caudal Approach in Open and Laparoscopic Radical Right Hemicolectomy for Right Colon Cancer
Right sided hemicolectomy is the standard type of operation for cancers in the caecum, the ascending colon, proximal transverse colon.The aim of this study was to assess the safety and feasibility of combined medial and caudal approach in performing right hemicolectomy and to compare outcome between laparoscopic and open surgery in right colon cancer.
Read the detailed description
The incidence of colorectal cancer is increasing. Slight shift towards right colon cancer is noticed in the last 2 decades in Egypt. This can be attributed to advances in diagnostic tools and increased public health awareness as right sided colon cancer was almost presented late as most of tumors located in the capacious cecum. Hence, early diagnosis with good radical procedure offers better outcome, quality of life and survival. Many approaches for right colon resection were described. In this study we adopted the combined medial and caudal approach for right colon resection in cases of right colon cancer in both open and laparoscopic techniques.
Traditionally, approach to right colon cancer is through open exploration but this approach has more blood loss, prolonged postoperative hospital stay, sever postoperative pain and delayed recovery.
As combined medial and caudal approach is a radical procedure,the purpose of the present study was to compare between laparoscopic and open right hemicolectomy both done with combined medial and caudal approach in right colon cancer as regards technical feasibility, advantages and disadvantages of both procedures.
This was prospective randomized study and was carried out on 26 participants as number of cases with right hemicolon cancer is about 2 per month in our center. Those participants diagnosed as operable right sided colon cancer and the participants were divided into two groups:
Group I: Open combined medial and caudal right hemicolectomy included 13 participants Group II: Laparoscopic combined medial and caudal right hemicolectomy included 13 participants
All patients with inclusion criteria were subjected to preoperative assessment in the form of:
- Full history.
- Clinical evaluation.
- Laboratory investigation (Complete blood picture, liver function tests, blood sugar, blood urea, serum creatinine, prothrombin time, serum albumin and tumour marker CEA).
- Imaging (chest X-ray, US abdomen, CT abdomen and pelvis).
- Histopathology diagnosis (endoscopic biopsy, tissue diagnosis).
- Determined whether participants underwent open or laparoscopic operation is multifactorial e.g., patients desire, contraindications for laparoscopy and mass size if more than 5 cm preferred to have open surgery.
- Informed written consent taken from the patients or the legal guardian. operative technique: both groups offered combined medial and caudal approach
- Fasting for 6 hours with no oral intake or only clear fluids intake the day before or better bowel preparation.
- After confirming the availability of blood of matching blood group, general anesthesia is inducted and prophylactic antibiotics are given.
- Patient positioning:
- group I: (Open cases) The standard position for an open right hemicolectomy is supine with strapping of the ankle and wrists, such as the Trendelenburg position. The surgeon stands on the patient's left, and the first assistant stands across from the surgeon on the patient's right. The scrub nurse stands beside the surgeon. If a second assistant is needed, he or she usually stands across from the surgeon to the left of the first assistant.
- group II: laparoscopic cases: The patient should be placed in the supine position with his two legs apart and arms tucked beside the body.
The surgeon should stand between the patient's legs with the assistant standing on the patient's left and the camera operator standing on the assistant's left side, and the scrub nurse on the patient's right side.
The video monitor is placed on the patient's upper right.
- Abdominal access and trocar placement by open or closed technique using veress needle for pneumoperitoneum with an intraperitoneal pressure of 14 mmHg.
- The procedure requires 5 trocars.
- A 10 mm trocar is placed 3 cm below umbilicus for the 30° angled telescope to get an adequate view. The incision would be enlarged to extract the specimen and performing anastomosis.
- A12 mm trocar is introduced 5 cm below the telescope port for the surgeon right hand instrument.
- A 5 mm port is inserted at the McBurney's point for the surgeon's left hand instrument.
- Additional two 5 mm trocars are placed at the opposite of McBurney's point and the right subcostal position respectively for the assistant to retract and display the colon and mesocolon.
Intraoperatively, all patients will be assessed for:
- Time of the procedure.
- Amount of blood loss. post operatively: Postoperative medications given. Monitoring of vital signs and drains. post operative assesment of pain is subjective to the participant as he gave it a score from 1 to 10. minimal pain score(1 to 3), mild (4 to 6) and sever (7 to 10). Ambulation and clear oral fluids started when intestinal sounds are audible followed by soft diet. The intraperitoneal tube drain removed when there is less than 50cc of fluid per 24h or after performing ultrasonography.
Follow up:
Participants are reviewed as outpatients weekly for 1 month or more frequent if they develop any complications between their visits.
The postoperative pathological results, number of lymph node dissection, postoperative exhaust time, postoperative abdominal drain volume and duration, postoperative short term complications, hospital stay and postoperative pathological staging will be recorded.
- Conditions
- Colon Cancer
- Being tested
- combined medial and caudal approach right hemicolectomy open and laparoscopic
- Keywords
- right colon, medial and caudal approach, hemicolectomy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined medial and caudal approach right hemicolectomy open and laparoscopicProcedure or surgery
resection of right colon cancer by this radical approach
| Study group | Role | What they receive |
|---|---|---|
| open right hemicolectomy | Active comparator | participants diagnosed as operable right sided colon cancer were enrolled in this study and did open combined medial and caudal resection procedure Receives: Procedure: combined medial and caudal approach right hemicolectomy open and laparoscopic |
| laparoscopic right hemicolectomy | Active comparator | participants diagnosed as operable right sided colon cancer were enrolled in this study and did laparoscopic combined medial and caudal resection procedure Receives: Procedure: combined medial and caudal approach right hemicolectomy open and laparoscopic |
What is being measured
The primary outcome is the main question the study is designed to answer.
calculate the duration of operation in both groups
The duration of operation was calculated in minutes in both groups. group I: open combined medial and caudal right hemicolectomy and group II: laparoscopic combined medial and caudal right hemicolectomy from skin incision till skin closure intraoperatively.
Measured: The duration of operation was calculated intra operatively from skin incision to skin closure. it was ranging from 2 to 4 hours after skin incision.
Detection of the amount of blood loss during operation in both groups.
the amount of blood loss during operation is calculated in cubic centimetres using scaled container connected to suction device in both groups.
Measured: the amount of blood loss was detected intra operatively for 4 hours after skin incision.
Detection of organ or visceral injury in both groups
detection of organ or visceral injury was done intra operatively by naked eye in both groups.
Measured: detection of organ injury was detected intra operatively for 4 hours after skin incision.
detection of the duration of hospital stay in both groups
the duration of hospital stay was detected in days in both groups
Measured: duration of hospital stay was detected from the day of operation till the day of discharge (4 to 7 days postoperatively)
detection of number of resected lymph nodes in both groups
the number of resected lymph nodes was detected in post operative histopathological reports in both groups.
Measured: number of resected lymph nodes was detected from 7th to 10th day post operatively
detection of occurrence of postoperative pain in both groups
detection of post operative pain was detected in both groups using a written scale fulfilled by the participant giving a score from 1 out of 10 points (1 to 3 points referred as minimal) (4 to 6 points referred as mild) (7 to 10 points referred as sever).
Measured: detection of post operative pain in both groups was done from the day of operation to 7 days postoperatively.
detection of occurrence fecal fistula in both groups
occurrence of fecal fistula in both groups was detected by vision of fecal discharge in drains from 48 hours post operatively till discharge day.
Measured: detection of occurrence of fecal fistula in both groups was detected from 2 to 7 days postoperatively
detection of post operative wound infection in both groups
post operative wound infection in both groups was detected by vision of wound discharge or pus.
Measured: post operative wound infection in both groups was detected from 2 days to one month post operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start7 Aug 2020
- Primary completion28 Aug 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- all participants underwent right hemicolectomy using combined medial and caudal approach and divided into 2 groups group I had open surgery and group II had laparoscopic surgery
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Reham Zakaria Mohamed Ahmed, Zagazig University
- Investigators
- Reham Z Mohamed, master, Principal investigator, assistant lecturer of general surgery zagazig universityAli H Elshewy, PhD, Study director, professor of general surgery zagazig universityAbdelrahman A Sarhan, PhD, Study chair, professor of general surgery zagazig universityGamal M Osman, PhD, Study director, assistant professor of general surgery zagazig university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128708
- Sponsor's protocol ID
- #6199-29-6-2020
- Other IDs
- zagazig university
- Status last verified
- Nov 2021
- First submitted
- 4 Nov 2021
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: researchers should contact the principle investigator for individual participant data
Publications
Troisi RJ, Freedman AN, Devesa SS. Incidence of colorectal carcinoma in the U.S.: an update of trends by gender, race, age, subsite, and stage, 1975-1994. Cancer. 1999 Apr 15;85(8):1670-6.
PubMed 10223559Gouvas N, Agalianos C, Papaparaskeva K, Perrakis A, Hohenberger W, Xynos E. Surgery along the embryological planes for colon cancer: a systematic review of complete mesocolic excision. Int J Colorectal Dis. 2016 Sep;31(9):1577-94. doi: 10.1007/s00384-016-2626-2. Epub 2016 Jul 28.
PubMed 27469525Jessup JM, McGinnis LS, Steele GD Jr, Menck HR, Winchester DP. The National Cancer Data Base. Report on colon cancer. Cancer. 1996 Aug 15;78(4):918-26. doi: 10.1002/(SICI)1097-0142(19960815)78:43.0.CO;2-W.
PubMed 8756390Chen Q, Shuai X, Chen L. [Safety and feasibility of the combined medial and caudal approach in laparoscopic D3 lymphadenectomy plus complete mesocolic excision for right hemicolectomy in the treatment of right hemicolon cancer complicated with incomplete ileus]. Zhonghua Wei Chang Wai Ke Za Zhi. 2018 Sep 25;21(9):1039-1044. Chinese.
PubMed 30269325Li F, Zhou X, Wang B, Guo L, Wang J, Wang W, Fu W. Comparison between different approaches applied in laparoscopic right hemi-colectomy: A systematic review and network meta-analysis. Int J Surg. 2017 Dec;48:74-82. doi: 10.1016/j.ijsu.2017.10.029. Epub 2017 Oct 12.
PubMed 29032159Xie D, Yu C, Gao C, Osaiweran H, Hu J, Gong J. An Optimal Approach for Laparoscopic D3 Lymphadenectomy Plus Complete Mesocolic Excision (D3+CME) for Right-Sided Colon Cancer. Ann Surg Oncol. 2017 May;24(5):1312-1313. doi: 10.1245/s10434-016-5722-1. Epub 2016 Dec 19.
PubMed 27995452
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of the Combined Medial and Caudal Approach in Open and Laparoscopic Radical Right Hemicolectomy for Right Colon Cancer
- ClinicalTrials.gov ID
- NCT05128708
- Acronym / sponsor ID
- #6199-29-6-2020
- Conditions
- Colon Cancer
- Keywords
- right colon, medial and caudal approach, hemicolectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 7 Aug 2020 (actual)
- Primary completion
- 28 Aug 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Right sided hemicolectomy is the standard type of operation for cancers in the caecum, the ascending colon, proximal transverse colon.The aim of this study was to assess the safety and feasibility of combined medial and caudal approach in performing right hemicolectomy and to compare outcome between laparoscopic and open surgery in right colon cancer.
Detailed description
The incidence of colorectal cancer is increasing. Slight shift towards right colon cancer is noticed in the last 2 decades in Egypt. This can be attributed to advances in diagnostic tools and increased public health awareness as right sided colon cancer was almost presented late as most of tumors located in the capacious cecum. Hence, early diagnosis with good radical procedure offers better outcome, quality of life and survival. Many approaches for right colon resection were described. In this study we adopted the combined medial and caudal approach for right colon resection in cases of right colon cancer in both open and laparoscopic techniques.
Traditionally, approach to right colon cancer is through open exploration but this approach has more blood loss, prolonged postoperative hospital stay, sever postoperative pain and delayed recovery.
As combined medial and caudal approach is a radical procedure,the purpose of the present study was to compare between laparoscopic and open right hemicolectomy both done with combined medial and caudal approach in right colon cancer as regards technical feasibility, advantages and disadvantages of both procedures.
This was prospective randomized study and was carried out on 26 participants as number of cases with right hemicolon cancer is about 2 per month in our center. Those participants diagnosed as operable right sided colon cancer and the participants were divided into two groups:
Group I: Open combined medial and caudal right hemicolectomy included 13 participants Group II: Laparoscopic combined medial and caudal right hemicolectomy included 13 participants
All patients with inclusion criteria were subjected to preoperative assessment in the form of:
- Full history.
- Clinical evaluation.
- Laboratory investigation (Complete blood picture, liver function tests, blood sugar, blood urea, serum creatinine, prothrombin time, serum albumin and tumour marker CEA).
- Imaging (chest X-ray, US abdomen, CT abdomen and pelvis).
- Histopathology diagnosis (endoscopic biopsy, tissue diagnosis).
- Determined whether participants underwent open or laparoscopic operation is multifactorial e.g., patients desire, contraindications for laparoscopy and mass size if more than 5 cm preferred to have open surgery.
- Informed written consent taken from the patients or the legal guardian. operative technique: both groups offered combined medial and caudal approach
- Fasting for 6 hours with no oral intake or only clear fluids intake the day before or better bowel preparation.
- After confirming the availability of blood of matching blood group, general anesthesia is inducted and prophylactic antibiotics are given.
- Patient positioning:
- group I: (Open cases) The standard position for an open right hemicolectomy is supine with strapping of the ankle and wrists, such as the Trendelenburg position. The surgeon stands on the patient's left, and the first assistant stands across from the surgeon on the patient's right. The scrub nurse stands beside the surgeon. If a second assistant is needed, he or she usually stands across from the surgeon to the left of the first assistant.
- group II: laparoscopic cases: The patient should be placed in the supine position with his two legs apart and arms tucked beside the body.
The surgeon should stand between the patient's legs with the assistant standing on the patient's left and the camera operator standing on the assistant's left side, and the scrub nurse on the patient's right side.
The video monitor is placed on the patient's upper right.
- Abdominal access and trocar placement by open or closed technique using veress needle for pneumoperitoneum with an intraperitoneal pressure of 14 mmHg.
- The procedure requires 5 trocars.
- A 10 mm trocar is placed 3 cm below umbilicus for the 30° angled telescope to get an adequate view. The incision would be enlarged to extract the specimen and performing anastomosis.
- A12 mm trocar is introduced 5 cm below the telescope port for the surgeon right hand instrument.
- A 5 mm port is inserted at the McBurney's point for the surgeon's left hand instrument.
- Additional two 5 mm trocars are placed at the opposite of McBurney's point and the right subcostal position respectively for the assistant to retract and display the colon and mesocolon.
Intraoperatively, all patients will be assessed for:
- Time of the procedure.
- Amount of blood loss. post operatively: Postoperative medications given. Monitoring of vital signs and drains. post operative assesment of pain is subjective to the participant as he gave it a score from 1 to 10. minimal pain score(1 to 3), mild (4 to 6) and sever (7 to 10). Ambulation and clear oral fluids started when intestinal sounds are audible followed by soft diet. The intraperitoneal tube drain removed when there is less than 50cc of fluid per 24h or after performing ultrasonography.
Follow up:
Participants are reviewed as outpatients weekly for 1 month or more frequent if they develop any complications between their visits.
The postoperative pathological results, number of lymph node dissection, postoperative exhaust time, postoperative abdominal drain volume and duration, postoperative short term complications, hospital stay and postoperative pathological staging will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- all participants underwent right hemicolectomy using combined medial and caudal approach and divided into 2 groups group I had open surgery and group II had laparoscopic surgery
| Arm | Type | Receives |
|---|---|---|
| open right hemicolectomy | Active comparator | Procedure: combined medial and caudal approach right hemicolectomy open and laparoscopicparticipants diagnosed as operable right sided colon cancer were enrolled in this study and did open combined medial and caudal resection procedure |
| laparoscopic right hemicolectomy | Active comparator | Procedure: combined medial and caudal approach right hemicolectomy open and laparoscopicparticipants diagnosed as operable right sided colon cancer were enrolled in this study and did laparoscopic combined medial and caudal resection procedure |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed right colon cancer with colonoscopic biopsy.
- No invasion of the surrounding tissue.
- No distant metastasis except the liver.
Key exclusion criteria (6 listed)
- Informed consent refusal
- Malignancy recurrence
- Distant metastasis except the liver.
- Locally advanced tumor.
- participants need emergent intervention e.g., intestinal obstruction or perforation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| combined medial and caudal approach right hemicolectomy open and laparoscopicresection of right colon cancer by this radical approach | Procedure or surgery | laparoscopic right hemicolectomy, open right hemicolectomy |
Primary outcome
calculate the duration of operation in both groups
Time frame: The duration of operation was calculated intra operatively from skin incision to skin closure. it was ranging from 2 to 4 hours after skin incision.
The duration of operation was calculated in minutes in both groups. group I: open combined medial and caudal right hemicolectomy and group II: laparoscopic combined medial and caudal right hemicolectomy from skin incision till skin closure intraoperatively.
Detection of the amount of blood loss during operation in both groups.
Time frame: the amount of blood loss was detected intra operatively for 4 hours after skin incision.
the amount of blood loss during operation is calculated in cubic centimetres using scaled container connected to suction device in both groups.
Detection of organ or visceral injury in both groups
Time frame: detection of organ injury was detected intra operatively for 4 hours after skin incision.
detection of organ or visceral injury was done intra operatively by naked eye in both groups.
detection of the duration of hospital stay in both groups
Time frame: duration of hospital stay was detected from the day of operation till the day of discharge (4 to 7 days postoperatively)
the duration of hospital stay was detected in days in both groups
detection of number of resected lymph nodes in both groups
Time frame: number of resected lymph nodes was detected from 7th to 10th day post operatively
the number of resected lymph nodes was detected in post operative histopathological reports in both groups.
detection of occurrence of postoperative pain in both groups
Time frame: detection of post operative pain in both groups was done from the day of operation to 7 days postoperatively.
detection of post operative pain was detected in both groups using a written scale fulfilled by the participant giving a score from 1 out of 10 points (1 to 3 points referred as minimal) (4 to 6 points referred as mild) (7 to 10 points referred as sever).
detection of occurrence fecal fistula in both groups
Time frame: detection of occurrence of fecal fistula in both groups was detected from 2 to 7 days postoperatively
occurrence of fecal fistula in both groups was detected by vision of fecal discharge in drains from 48 hours post operatively till discharge day.
detection of post operative wound infection in both groups
Time frame: post operative wound infection in both groups was detected from 2 days to one month post operatively.
post operative wound infection in both groups was detected by vision of wound discharge or pus.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Background: PubMed 10223559Troisi RJ, Freedman AN, Devesa SS. Incidence of colorectal carcinoma in the U.S.: an update of trends by gender, race, age, subsite, and stage, 1975-1994. Cancer. 1999 Apr 15;85(8):1670-6.
- Background: PubMed 27469525Gouvas N, Agalianos C, Papaparaskeva K, Perrakis A, Hohenberger W, Xynos E. Surgery along the embryological planes for colon cancer: a systematic review of complete mesocolic excision. Int J Colorectal Dis. 2016 Sep;31(9):1577-94. doi: 10.1007/s00384-016-2626-2. Epub 2016 Jul 28.
- Background: PubMed 8756390Jessup JM, McGinnis LS, Steele GD Jr, Menck HR, Winchester DP. The National Cancer Data Base. Report on colon cancer. Cancer. 1996 Aug 15;78(4):918-26. doi: 10.1002/(SICI)1097-0142(19960815)78:43.0.CO;2-W.
- Background: PubMed 30269325Chen Q, Shuai X, Chen L. [Safety and feasibility of the combined medial and caudal approach in laparoscopic D3 lymphadenectomy plus complete mesocolic excision for right hemicolectomy in the treatment of right hemicolon cancer complicated with incomplete ileus]. Zhonghua Wei Chang Wai Ke Za Zhi. 2018 Sep 25;21(9):1039-1044. Chinese.
- Background: PubMed 29032159Li F, Zhou X, Wang B, Guo L, Wang J, Wang W, Fu W. Comparison between different approaches applied in laparoscopic right hemi-colectomy: A systematic review and network meta-analysis. Int J Surg. 2017 Dec;48:74-82. doi: 10.1016/j.ijsu.2017.10.029. Epub 2017 Oct 12.
- Background: PubMed 27995452Xie D, Yu C, Gao C, Osaiweran H, Hu J, Gong J. An Optimal Approach for Laparoscopic D3 Lymphadenectomy Plus Complete Mesocolic Excision (D3+CME) for Right-Sided Colon Cancer. Ann Surg Oncol. 2017 May;24(5):1312-1313. doi: 10.1245/s10434-016-5722-1. Epub 2016 Dec 19.
- Individual participant dataSharing planned: No. researchers should contact the principle investigator for individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reham Z Mohamed, master principal investigator
assistant lecturer of general surgery zagazig university
Ali H Elshewy, PhD study director
professor of general surgery zagazig university
Abdelrahman A Sarhan, PhD study chair
professor of general surgery zagazig university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined medial and caudal approach right hemicolectomy open and laparoscopic in people with Colon Cancer, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
calculate the duration of operation in both groups (time frame: The duration of operation was calculated intra operatively from skin incision to skin closure. it was ranging from 2 to 4 hours after skin incision.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05128708, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.