Clinical trial · Interventional
Drainage After Rectal Excision for Rectal Cancer
Randomized Trial Comparing Drainage Versus no Drainage Following Rectal Excision With Low Anastomosis for Rectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multicenter Study | — | UNRESOLVED | — |
| Pelvic Drainage | — | UNRESOLVED | — |
| Randomized Clinical Trial | — | UNRESOLVED | — |
| Rectal Cancer Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laying and management of the drain (strictly randomized arm with drainage) | Procedure | — | UNRESOLVED |
| No pelvic drainage | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Drainage
- description
- Rectal excision with aspiration pelvic drainage
- interventionNames
- Procedure: Laying and management of the drain (strictly randomized arm with drainage)
- type
- EXPERIMENTAL
- label
- No drainage
- description
- Rectal excision without aspiration pelvic drainage
- interventionNames
- Procedure: No pelvic drainage
Primary outcomes (1)
- measure
- Pelvic sepsis
- timeFrame
- within the first 30 days after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- RESULTDenost Q, Rouanet P, Faucheron JL, Panis Y, Meunier B, Cotte E, Meurette G, Kirzin S, Sabbagh C, Loriau J, Benoist S, Mariette C, Sielezneff I, Lelong B, Mauvais F, Romain B, Barussaud ML, Germain C, Picat MQ, Rullier E, Laurent C; French Research Group of Rectal Cancer Surgery (GRECCAR). To Drain or Not to Drain Infraperitoneal Anastomosis After Rectal Excision for Cancer: The GRECCAR 5 Randomized Trial. Ann Surg. 2017 Mar;265(3):474-480. doi: 10.1097/SLA.0000000000001991. PMID 27631776
- RESULT2017 European Society of Coloproctology (ESCP) collaborating group. Safety of primary anastomosis following emergency left sided colorectal resection: an international, multi-centre prospective audit. Colorectal Dis. 2018 Sep;20 Suppl 6:47-57. doi: 10.1111/codi.14373. PMID 30255647