Intraoperative Blood LossNCT05923151
The Cranial-caudal Mixed Medial Approach for Laparoscopic Right Hemicolectomy
A study testing The cranial-caudal mixed medial approach in people with Intraoperative Blood Loss and Postoperative Complications, run by Jie Wang at 1 site in China.
Trial summary
To explore the feasibility and effectiveness of the cranial-caudal mixed medial approach in laparoscopic right hemicolectomy with complete mesocolic excision. Laparoscopic right hemicolectomy using the cranial-caudal mixed medial approach is safe and feasible, can shorten the operation time, reduce the risk of… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intraoperative Blood Loss, Postoperative Complications, Pathology
- What is being tested?
- The cranial-caudal mixed medial approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2017to 1 Feb 2023
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range: 18-70 years old
- Right colon cancer confirmed by colonoscopy and pathological diagnosis
- Single primary tumor without distal metastasis
- Laparoscopic operation
Who cannot join
- Age below 18 and above 70 years old
- Patients who need urgent surgery
- Persons with a history of malignant tumors
- Multiple primary tumors or distant metastases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Techniques and Advantages of the Cranial-caudal Mixed Medial Approach for Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision
To explore the feasibility and effectiveness of the cranial-caudal mixed medial approach in laparoscopic right hemicolectomy with complete mesocolic excision. Laparoscopic right hemicolectomy using the cranial-caudal mixed medial approach is safe and feasible, can shorten the operation time, reduce the risk of intraoperative bleeding, and has good clinical results.
Read the detailed description
The data of patients undergoing laparoscopic right hemicolectomy performed in the same surgical group of gastrointestinal surgery at Northern Jiangsu People's Hospital from February 2017 to June 2022 were retrospectively analyzed. According to different surgical approaches, patients were divided into the cranial-caudal mixed medial approach group and the medial approach group.
Intraoperative and postoperative data were collected. Intraoperative data is obtained through surgical records and pathological reports, including total operation time, Laparoscopic procedure time, Intraoperative blood loss, sample length, number of lymph nodes collected, and number of positive lymph nodes. Postoperative data includes exhaust time, liquid intake time, postoperative hospitalization and complications. Among them, complications are short-term postoperative complications (surgical related complications, non-surgical related complications) within the first 30 days after surgery (or throughout the hospitalization period, if more than 30 days, and are classified according to the Clavien-Dindo classification method.
To explore the feasibility and effectiveness of the cranial-caudal mixed medial approach in laparoscopic right hemicolectomy with complete mesocolic excision.
- Being tested
- The cranial-caudal mixed medial approach
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The cranial-caudal mixed medial approachProcedure or surgery
Expose the fusion fascia of Transverse colon mesocolon and stomach, and cut the gastrocolic ligament. The mesentery of Transverse colon was dissociated from the medial side to the lateral side along the gastroepiploic vessels to expose the branches of Henle's trunk and the right colon vessels. The dorsal mesentery of the small intestine is cut along the "yellow white line", and free cephalically along the Toldt space to separate the posterior space of the Ascending colon and the anterior space of the pancreas and duodenum behind the Transverse colon. The right colon blood vessels were dissected along SMV from the projection of ileocolic blood vessels, and the blood vessels were cut off by high ligation, and the lymph nodes at the root of Mesentery were cleared. Through a small incision in the middle of the abdomen, the right colon and mesentery were completely removed to complete digestive tract reconstruction.
| Study group | Role | What they receive |
|---|---|---|
| The cranial-caudal mixed medial approach group | Experimental | 75 patients were diagnosed with right colon cancer and underwent the cranial-caudal mixed medial approach for laparoscopic right hemicolectomy with complete mesocolic excision. Receives: Procedure: The cranial-caudal mixed medial approach |
| the medial approach group | Other | 73 patients were diagnosed with right colon cancer and underwent the medial approach for laparoscopic right hemicolectomy with complete mesocolic excision. Receives: Procedure: The cranial-caudal mixed medial approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
The operative time
The length of operative time
Measured: Surgery start (skin incision time) - Surgery end (suture incision end time)
Secondary outcomes (1)
Intraoperative blood loss
Measurement by gauze transfusion weighing method: soaked 32cm × A 20cm sized gauze loses approximately 30ml of blood; Soak 36cm × A 36cm sized gauze loses approximately 50ml of blood.
Measured: Surgery start (skin incision time) - Surgery end (suture incision end time)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start1 Feb 2017
- Primary completion30 Jun 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative Blood LossStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jie Wang
- Sponsor type
- University, hospital or other
- Collaborators
- Yangzhou University
- Responsible party
- Sponsor-investigator, Jie Wang, Subei People's Hospital of Jiangsu Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923151
- Sponsor's protocol ID
- SubeiH
- Status last verified
- Jun 2023
- First submitted
- 9 Jun 2023
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Techniques and Advantages of the Cranial-caudal Mixed Medial Approach for Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision
- ClinicalTrials.gov ID
- NCT05923151
- Acronym / sponsor ID
- SubeiH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Jie WangUniversity, hospital or other
- Collaborators
- Yangzhou University
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 28 Jun 2023 (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.
To explore the feasibility and effectiveness of the cranial-caudal mixed medial approach in laparoscopic right hemicolectomy with complete mesocolic excision. Laparoscopic right hemicolectomy using the cranial-caudal mixed medial approach is safe and feasible, can shorten the operation time, reduce the risk of intraoperative bleeding, and has good clinical results.
Detailed description
The data of patients undergoing laparoscopic right hemicolectomy performed in the same surgical group of gastrointestinal surgery at Northern Jiangsu People's Hospital from February 2017 to June 2022 were retrospectively analyzed. According to different surgical approaches, patients were divided into the cranial-caudal mixed medial approach group and the medial approach group.
Intraoperative and postoperative data were collected. Intraoperative data is obtained through surgical records and pathological reports, including total operation time, Laparoscopic procedure time, Intraoperative blood loss, sample length, number of lymph nodes collected, and number of positive lymph nodes. Postoperative data includes exhaust time, liquid intake time, postoperative hospitalization and complications. Among them, complications are short-term postoperative complications (surgical related complications, non-surgical related complications) within the first 30 days after surgery (or throughout the hospitalization period, if more than 30 days, and are classified according to the Clavien-Dindo classification method.
To explore the feasibility and effectiveness of the cranial-caudal mixed medial approach in laparoscopic right hemicolectomy with complete mesocolic excision.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The cranial-caudal mixed medial approach group | Experimental | Procedure: The cranial-caudal mixed medial approach75 patients were diagnosed with right colon cancer and underwent the cranial-caudal mixed medial approach for laparoscopic right hemicolectomy with complete mesocolic excision. |
| the medial approach group | Other | Procedure: The cranial-caudal mixed medial approach73 patients were diagnosed with right colon cancer and underwent the medial approach for laparoscopic right hemicolectomy with complete mesocolic excision. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age range: 18-70 years old
- Right colon cancer confirmed by colonoscopy and pathological diagnosis
- Single primary tumor without distal metastasis
- Laparoscopic operation
Key exclusion criteria (4 listed)
- Age below 18 and above 70 years old
- Patients who need urgent surgery
- Persons with a history of malignant tumors
- Multiple primary tumors or distant metastases
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 |
|---|---|---|
| The cranial-caudal mixed medial approachExpose the fusion fascia of Transverse colon mesocolon and stomach, and cut the gastrocolic ligament. The mesentery of Transverse colon was dissociated from the medial side to the lateral side along the gastroepiploic vessels to expose the branches of Henle's trunk and the right colon vessels. The dorsal mesentery of the small intestine is cut along the "yellow white line", and free cephalically along the Toldt space to separate the posterior space of the Ascending colon and the anterior space of the pancreas and duodenum behind the Transverse colon. The right colon blood vessels were dissected along SMV from the projection of ileocolic blood vessels, and the blood vessels were cut off by high ligation, and the lymph nodes at the root of Mesentery were cleared. Through a small incision in the middle of the abdomen, the right colon and mesentery were completely removed to complete digestive tract reconstruction. | Procedure or surgery | The cranial-caudal mixed medial approach group, the medial approach group |
Primary outcome
The operative time
Time frame: Surgery start (skin incision time) - Surgery end (suture incision end time)
The length of operative time
1 secondary outcome
Intraoperative blood loss
Time frame: Surgery start (skin incision time) - Surgery end (suture incision end time)
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 28 Jun 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The cranial-caudal mixed medial approach in people with Intraoperative Blood Loss and Postoperative Complications, run by Jie Wang at 1 site in China.
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 4 inclusion and 4 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 28 Jun 2023. 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 China. 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?
The operative time (time frame: Surgery start (skin incision time) - Surgery end (suture incision end time)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2023.