Drainage After Rectal Excision for Rectal Cancer

Study Overview
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Brief Summary
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After rectal excision, the rate of anastomotic leak and abscess is higher than after colic surgery. In order to limit and avoid the risk of pelvic sepsis after rectal excision, a prophylactic pelvic drainage is usually used. If current data have confirmed the uselessness of drainage in colic surgery, the question stay in abeyance in rectal surgery. This practice had never been evaluated in patients with rectal excision and low anastomosis (patients with a high risk of pelvic sepsis)

Detailed Description
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After rectal excision, the rate of anastomotic leak and abscess is higher than after colic surgery. In order to limit and avoid the risk of pelvic sepsis after rectal excision, a prophylactic pelvic drainage is usually used. If current data have confirmed the uselessness of drainage in colic surgery, the question stay in abeyance in rectal surgery. This practice had never been evaluated in patients with rectal excision and low anastomosis (patients with a high risk of pelvic sepsis) The aim of the study is to assess the impact of pelvic drainage vs. non pelvic drainage on risk of pelvic sepsis after rectal excision for cancer with infraperitoneal anastomosis. The principal objective is to compare the rate of pelvic sepsis until 30 days between the 2 groups of patients who had a rectal excision with and without pelvic drainage. It is a randomized clinical trial of superiority, multicentric, without blinding, in 2 parallel groups with ratio (1:1): distribution of the number of patients in the groups.

Official Title
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Randomized Trial Comparing Drainage Versus no Drainage Following Rectal Excision With Low Anastomosis for Rectal Cancer

Conditions
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Rectal Cancer Surgery, Randomized Clinical Trial, Multicenter Study, Pelvic Drainage

Intervention / Treatment
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* Procedure: Laying and management of the drain (strictly randomized arm with drainage)
* Procedure: No pelvic drainage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rectal adenocarcinoma, histopathologically proved, with or without neoadjuvant treatment Stapler or manual infraperitoneal anastomosis With or without stoma With bowel preparation Open or laparoscopic approach Stage T1-T4 Nx Mx Age 18 years old or older Information of the patient and signature of informed consent Affiliation to a regime of social insurance Exclusion Criteria: Colonic cancer (> 15 cm from anal verge) Abdominoperineal resection Associated resection (prostate, seminal bladder, vagina…) Simultaneous liver resection Total coloproctectomy Emergency Infected rectal tumour Pregnant women, suitable to be, or current suckling Persons deprived of freedom or under guardianship Persons under protection of justice Impossibility to accept the medical follow-up of the study for geographic , social or psychic reasons.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drainage<br>Rectal excision with aspiration pelvic drainage | Procedure: Laying and management of the drain (strictly randomized arm with drainage)<br>* At the end of intervention, the surgeon will position an aspiration drain in order to permit a postoperative pelvic drainage. The drain will be positioned forward sacrum, behind anastomosis. The drain will be leaved in place between 3 and 5 days. The criteria of drain ablation are the absence of haemorrhagic liquid and/or un daily debit < 100ml. Nursing care will be daily with change of bottle for collect pelvic serosity, accounting of quantity of collected liquid and realization of a dried bandage through contact with penetration of the drain.<br>|
| Experimental: No drainage<br>Rectal excision without aspiration pelvic drainage | Procedure: No pelvic drainage<br>* no aspiration drain at the end of intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic sepsis | Pelvic sepsis until 30 days after rectal excision is the primary end point. It is defined as the occurrence of an anastomotic leak revealed by peritonitis or discharge of gas, stools or pus, the vagina or the abdominal wound, and/or a pelvic abscess, between J0 and J30. | within the first 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall sepsis | Overall sepsis until 30 days (pelvic sepsis, wound abscess, urinary infection, pneumopathy, blood-poisoning) | up to 30 days after surgery | 
| Peri-operative mortality | Peri-operative mortality (hospital mortality and/or until 30 days after surgery if the patient is already going out of hospital) | up to 30 days after surgery | 
| Surgical morbidity according to Dindo classification | Surgical morbidity according to Dindo classification | within the first 6 months after surgery | 
| Re-surgery during the hospitalization |  | during the hospitalization | 
| Rate of closure of stoma | Rate of closure of stoma at 6 months | within the first 6 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectal Diseases, RectalNeoplasms, Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Digestive System Diseases, Gastrointestinal Diseases, Intestinal Diseases