Colon CancerEarly Phase 1NCT04977882
Abdominal Drainage, Postoperative Antibiotico-prophylaxis and CME With D3 Lyphadenectomy Effect on Gastrointestinal Function in Laparoscopic Right Hemicolectomy With Intracorporeal Anastomosis for Right Colon Cancer
A Early Phase 1 study testing abdominal drainage, Postoperative antibiotico-prophylaxis and Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC) in people with Colon Cancer, run by University of Rome Tor Vergata at 1 site in Italy.
Trial summary
Monocentric, two-level factorial, parallel-arm, pilot randomized clinical trial, conducted comparing patients undergoing laparoscopic right hemicolectomy with ICA for right colon cancer in a single unit of a teaching hospital: Minimally Invasive Surgery Unit, Department of Surgical Sciences, Policlinico Tor Vergata… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- abdominal drainage, Postoperative antibiotico-prophylaxis and Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2020to 1 Aug 2023
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Right colon cancer
- Intracorporeal anastomosis
- Laparoscopic surgery
- Elective surgery
- informed consent signed
Who cannot join
- below 18 years old
- IBD
- ASA IV
- T4b
- Metastatic disease
- Preoperative steroids
Show all 11Show fewer
- Conversion to open surgery
- Emergency surgery
- concomitant major operation
- preoperative infective status
- benign disease
Trial locations and contacts
1 site in 1 country.
About this study
Monocentric, two-level factorial, parallel-arm, pilot randomized clinical trial, conducted comparing patients undergoing laparoscopic right hemicolectomy with ICA for right colon cancer in a single unit of a teaching hospital: Minimally Invasive Surgery Unit, Department of Surgical Sciences, Policlinico Tor Vergata, Rome, Italy.
- Conditions
- Colon Cancer
- Being tested
- abdominal drainage, Postoperative antibiotico-prophylaxis, Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC), Laparoscopic standard D2 right hemicolectomy (STANDARD)
- Keywords
- intracorporeal anastomosis, right hemicoletomy, colon cancer
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominal drainageProcedure or surgery
19 Fr abdominal drainage placed intraoperatively in right colic gutter
Postoperative antibiotico-prophylaxisDrug
Ceftriaxone 2 gr and Metronidazole 1.5 gr per day for 2 days postoperatively
Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC)Procedure or surgery
the dissection starts over the landmark given by SMV. The SMV is freed anteriorly and on its right-hand side from all the lympho-adipose tissue. Once the SMV is fully exposed, the IC vessels are dissected and divided at the junction with the efferent vessels. The dissection moves upward along the same dissection line to identify the right colic vein and the GCTH. No medial to later dissection is carried out until the SMV is completely exposed before reaching the uncinate process of the pancreas. At this point the veins to the right colon are divided but gastroepiploic vein and artery are preserved unless the tumor is located at the hepatic flexure. The divided mesentery is lifted and tilted to the right, and the medial-to-later dissection starts following the embryological plane over Fredet's fascia. The mesocolon is divided on the right side of the middle colic artery and the right branches of the middle colic vessels are divided.
Laparoscopic standard D2 right hemicolectomy (STANDARD)Procedure or surgery
A medial-to-lateral surgical dissection and high tie of the ileocolic vessels (IC) is undertaken without dissecting the anterior surface of the superior mesenteric vein (SMV). The gastro-colic trunk of Henle (GCTH) is not isolated and the right colic vein (when present) and the right branches of the middle colic vessels are taken more peripherical, during the division of the transverse mesocolon. The right gastroepiploic vessels are not dissected, nor divided, unless in proximity of the tumor
| Study group | Role | What they receive |
|---|---|---|
| Abdominal drainage | Experimental | 19 Fr abdominal drainage placed intraoperatevely in right paracolic gutter Receives: Procedure: abdominal drainage; Procedure: Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC); Procedure: Laparoscopic standard D2 right hemicolectomy (STANDARD) |
| Postoperative antibiotico-prophylaxis | Experimental | postoperative antibiotico-prophylaxis with Ceftriaxone 2gr and Metronidazole 1.5gr Receives: Drug: Postoperative antibiotico-prophylaxis; Procedure: Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC); Procedure: Laparoscopic standard D2 right hemicolectomy (STANDARD) |
| Control group | Sham comparator | No drainage nor postoperative antibiotico-prophylaxis Receives: Procedure: Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC); Procedure: Laparoscopic standard D2 right hemicolectomy (STANDARD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance to solid diet
time to light diet tolerance
Measured: 30 days postoperatively
Secondary outcomes (12)
White blood cell
measured thousands/mL in I and III POD
Measured: 30 days postoperatively
Procalcitonine
measured ng/ml in III and V POD
Measured: 30 days postoperatively
Days of hospitalization
number of days of hospitalization
Measured: 90 days postoperatively
Readmission rate
rate of hospital readmission
Measured: 90 days postoperatively
Mortality rate
postoperative mortality
Measured: 90 days postoperatively
Surgical site infection rate
postoperative wound infection
Measured: 30 days postoperatively
Anastomotic leak rate
postoperative Ileocolic anastomotic leakage
Measured: 30 days postoperatively
Tolerance to liquid diet
time to clear fluid tolerance
Measured: 30 days postoperatively
Time to first flatus
Time to first flatus postoperatively
Measured: 30 days postoperatively
Time to first evacuation
Time to first evacuation postoperatively
Measured: 30 days postoperatively
need of abdomen CTscan rate
need of abdomen CTscan
Measured: 30 days postoperatively
C-Reactive Proteine
measured mg/L in I and III POD
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start1 Oct 2020
- Primary completion1 Aug 2022
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Patients were initially randomized for postoperative management into three arms to receive prolonged antibiotic prophylaxis (ABX group), abdominal drain placement (DRAIN group) or neither (NONE group) (I level randomization). The same patients were further randomized for surgical technique in two arms to receive RRC (RRC group) or standard hemicolectomy with D2 dissection (STANDARD group) (II level of randomization).
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Sigismondo Sica, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977882
- Sponsor's protocol ID
- Registro sperimentazioni XX.21
- Status last verified
- Nov 2023
- First submitted
- 15 Jul 2021
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sica GS, Siragusa L, Pirozzi BM, Sorge R, Baldini G, Fiorani C, Guida AM, Bellato V, Franceschilli M. Gastrointestinal functions after laparoscopic right colectomy with intracorporeal anastomosis: a pilot randomized clinical trial on effects of abdominal drain, prolonged antibiotic prophylaxis, and D3 lymphadenectomy with complete mesocolic excision. Int J Colorectal Dis. 2024 Jul 6;39(1):102. doi: 10.1007/s00384-024-04657-0.
PubMed 38970713
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Drainage, Postoperative Antibiotico-prophylaxis and CME With D3 Lyphadenectomy Effect on Gastrointestinal Function in Laparoscopic Right Hemicolectomy With Intracorporeal Anastomosis for Right Colon Cancer
- ClinicalTrials.gov ID
- NCT04977882
- Acronym / sponsor ID
- Registro sperimentazioni XX.21
- Conditions
- Colon Cancer
- Keywords
- intracorporeal anastomosis, right hemicoletomy, colon cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 27 Jul 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.
Monocentric, two-level factorial, parallel-arm, pilot randomized clinical trial, conducted comparing patients undergoing laparoscopic right hemicolectomy with ICA for right colon cancer in a single unit of a teaching hospital: Minimally Invasive Surgery Unit, Department of Surgical Sciences, Policlinico Tor Vergata, Rome, Italy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients were initially randomized for postoperative management into three arms to receive prolonged antibiotic prophylaxis (ABX group), abdominal drain placement (DRAIN group) or neither (NONE group) (I level randomization). The same patients were further randomized for surgical technique in two arms to receive RRC (RRC group) or standard hemicolectomy with D2 dissection (STANDARD group) (II level of randomization).
| Arm | Type | Receives |
|---|---|---|
| Abdominal drainage | Experimental | Procedure: abdominal drainage, Procedure: Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC), Procedure: Laparoscopic standard D2 right hemicolectomy (STANDARD)19 Fr abdominal drainage placed intraoperatevely in right paracolic gutter |
| Postoperative antibiotico-prophylaxis | Experimental | Drug: Postoperative antibiotico-prophylaxis, Procedure: Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC), Procedure: Laparoscopic standard D2 right hemicolectomy (STANDARD)postoperative antibiotico-prophylaxis with Ceftriaxone 2gr and Metronidazole 1.5gr |
| Control group | Sham comparator | Procedure: Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC), Procedure: Laparoscopic standard D2 right hemicolectomy (STANDARD)No drainage nor postoperative antibiotico-prophylaxis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Right colon cancer
- Intracorporeal anastomosis
- Laparoscopic surgery
- Elective surgery
- informed consent signed
Key exclusion criteria (11 listed)
- below 18 years old
- IBD
- ASA IV
- T4b
- Metastatic disease
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 |
|---|---|---|
| abdominal drainage19 Fr abdominal drainage placed intraoperatively in right colic gutter | Procedure or surgery | Abdominal drainage |
| Postoperative antibiotico-prophylaxisCeftriaxone 2 gr and Metronidazole 1.5 gr per day for 2 days postoperatively | Drug | Postoperative antibiotico-prophylaxis |
| Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC)the dissection starts over the landmark given by SMV. The SMV is freed anteriorly and on its right-hand side from all the lympho-adipose tissue. Once the SMV is fully exposed, the IC vessels are dissected and divided at the junction with the efferent vessels. The dissection moves upward along the same dissection line to identify the right colic vein and the GCTH. No medial to later dissection is carried out until the SMV is completely exposed before reaching the uncinate process of the pancreas. At this point the veins to the right colon are divided but gastroepiploic vein and artery are preserved unless the tumor is located at the hepatic flexure. The divided mesentery is lifted and tilted to the right, and the medial-to-later dissection starts following the embryological plane over Fredet's fascia. The mesocolon is divided on the right side of the middle colic artery and the right branches of the middle colic vessels are divided. | Procedure or surgery | Abdominal drainage, Control group, Postoperative antibiotico-prophylaxis |
| Laparoscopic standard D2 right hemicolectomy (STANDARD)A medial-to-lateral surgical dissection and high tie of the ileocolic vessels (IC) is undertaken without dissecting the anterior surface of the superior mesenteric vein (SMV). The gastro-colic trunk of Henle (GCTH) is not isolated and the right colic vein (when present) and the right branches of the middle colic vessels are taken more peripherical, during the division of the transverse mesocolon. The right gastroepiploic vessels are not dissected, nor divided, unless in proximity of the tumor | Procedure or surgery | Abdominal drainage, Control group, Postoperative antibiotico-prophylaxis |
Primary outcome
Tolerance to solid diet
Time frame: 30 days postoperatively
time to light diet tolerance
12 secondary outcomes
White blood cell
Time frame: 30 days postoperatively
Procalcitonine
Time frame: 30 days postoperatively
Days of hospitalization
Time frame: 90 days postoperatively
Readmission rate
Time frame: 90 days postoperatively
Mortality rate
Time frame: 90 days postoperatively
Surgical site infection rate
Time frame: 30 days postoperatively
Anastomotic leak rate
Time frame: 30 days postoperatively
Tolerance to liquid diet
Time frame: 30 days postoperatively
Time to first flatus
Time frame: 30 days postoperatively
Time to first evacuation
Time frame: 30 days postoperatively
need of abdomen CTscan rate
Time frame: 30 days postoperatively
C-Reactive Proteine
Time frame: 30 days postoperatively
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 2023.
- Derived from this study: PubMed 38970713Sica GS, Siragusa L, Pirozzi BM, Sorge R, Baldini G, Fiorani C, Guida AM, Bellato V, Franceschilli M. Gastrointestinal functions after laparoscopic right colectomy with intracorporeal anastomosis: a pilot randomized clinical trial on effects of abdominal drain, prolonged antibiotic prophylaxis, and D3 lymphadenectomy with complete mesocolic excision. Int J Colorectal Dis. 2024 Jul 6;39(1):102. doi: 10.1007/s00384-024-04657-0.
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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 Early Phase 1 study testing abdominal drainage, Postoperative antibiotico-prophylaxis and Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC) in people with Colon Cancer, run by University of Rome Tor Vergata at 1 site in Italy.
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 5 inclusion and 11 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 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 Italy. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Tolerance to solid diet (time frame: 30 days postoperatively). 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 NCT04977882, which also lists 1 linked publication.
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 2023.