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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-A00868-31 | Other Identifier | ANSM |
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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drainage | Active Comparator | Rectal excision with aspiration pelvic drainage |
|
| No drainage | Experimental | Rectal excision without aspiration pelvic drainage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laying and management of the drain (strictly randomized arm with drainage) | Procedure | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adélaïde Doussau, Dr | University Hospital, Bordeaux | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'AMIENS | Amiens | 80054 | France | |||
| CH de BEAUVAIS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27631776 | Result | Denost 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. | |
| 30255647 |
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|
| No pelvic drainage | Procedure | no aspiration drain at the end of intervention |
|
| 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 |
| Beauvais |
| 60021 |
| France |
| Service de Chirurgie Digestive - Hôpital Saint-André - CHU de Bordeaux | Bordeaux | 33075 | France |
| Service de Chirurgie Générale et Digestive - Hôpital Beaujon | Clichy | 92110 | France |
| Service de Chirurgie Digestive - Hôpital A. Michallon | La Tronche | 38700 | France |
| APHP-Kremlin Bicetre | Le Kremlin-Bicêtre | 94275 | France |
| Département de Chirurgie Oncologique - Centre Oscar Lambret | Lille | 59020 | France |
| CHRU Lille | Lille | 59037 | France |
| Centre Hospitalier Lyon Sud | Lyon | 69495 | France |
| Département de Chirurgie Oncologique - Institut Paoli Calmette | Marseille | 13009 | France |
| Service de Chirurgie Digestive et Viscérale - CHU Timone | Marseille | 13385 | France |
| Département de Chirurgie Oncologique - CRLC Val d'Aurelle | Montpellier | 34298 | France |
| Service de Chirurgie Digestive - CHU de Nantes - Hôtel Dieu | Nantes | 44093 | France |
| Service de Chirurgie Générale et Digestive - Hôpital Saint-Antoine | Paris | 75012 | France |
| APHP- Saint Joseph | Paris | 75014 | France |
| Service de Chirurgie Digestive - Hôpital des Diaconnesses - La Croix Saint-Simon | Paris | 75020 | France |
| CHU Poitiers | Poitiers | France |
| Service de Chirurgie Viscérale - CHU Pontchaillou | Rennes | 35033 | France |
| Service de Chirurgie Digestive - CHU Charles Nicolle | Rouen | 76031 | France |
| CHRU de Strasbourg | Strasbourg | 67000 | France |
| Service de Chirurgie Digestive - Hôpital Purpan - Pavillon Dieulafoy | Toulouse | 31059 | France |
| Service de Chirurgie Digestive et Générale - Brabois | Vandœuvre-lès-Nancy | 54511 | France |
| Result |
| 2017 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. |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D003108 | Colonic Diseases |
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| ID | Term |
|---|---|
| D010058 | Oviposition |
| D004322 | Drainage |
| ID | Term |
|---|---|
| D012098 | Reproduction |
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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