Pelvic Drain After Rectal Resection for Mid-low Rectal Cancer

Rectal Cancer Clinical Trial

— GECO1  

Official title:

Pelvic Drain After Rectal Resection for Mid-low Rectal Cancer: a Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04573621
• Other study ID #: GECO1
• Status: Recruiting
• Phase: N/A
• Start date: October 2020
• Est. completion date: September 2022

Study information

• Verified date: September 2020
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Eloy Espín-Basany
• Phone: 932746000
• Email: eespin[@]vhebron.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This RCT aims at assessing the effects of a pelvic drain after total mesorectal excision for mid-low rectal cancer on the rates of pelvic sepsis and anastomotic leaks.

Description:

This is a 2-arm, non-inferiority RCT. Patients undergoing total mesorectal excision for mid-low rectal cancer will be randomly assigned into two groups:

• pelvic drain

• no pelvic drain. Patients will be followed-up to assess the rates of anastomotic leaks, pelvic sepsis and secondary outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 518
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or Female, 18 year-of-age or above

• Mid or low rectal cancer

• Anastomosis below the peritoneal reflection

• Total mesorectal excision (TME)

• Capability to understand the study

• Informed consent

Exclusion Criteria:

• For women, pregnancy

• Chronic kidney failure or hepatic failure, immunodepression, malnoutrition

• Life expectancy < 6 months

• Partial mesorectal excision

• Abdominoperineal excision

• Multivisceral resections

• Emergency surgery

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Pelvic drain
A pelvic drain is placed

Other:
• No pelvic drain is placed
A pelvic drain is not placed

Locations

Country	Name	City	State
Spain	Hospital General Universitario Vall d´Hebron	Barcelona	Barcelona, Spain

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with pelvic sepsis	anastomotic leak or pelvic collections clinically or radiologically detected	0-30 days postoperatively
Secondary	Management of pelvic sepsis	Type of management (medical, rediological, surgical)	0-30 days postoperatively
Secondary	Postoperative complications	Overall postoperative complications	0-30 days postoperatively
Secondary	CT scan or imaging needed	Necessity of performing unscheduled imaging tests	0-30 days postoperatively
Secondary	Number of participants with postoperative ileus	Postoperative ileus	0-30 days postoperatively
Secondary	Diagnostic delay for a leak	Days between surgery and leak detection	0-30 days postoperatively
Secondary	Length of postperative stay	Days of stay after surgery	0-30 days postoperatively or until discharge
Secondary	Time to flatus and bowel movement	Days between surgery and flatus/faeces	0-30 days postoperatively
Secondary	Stoma presence at 1-year follow-up	Necessity of maintaining the diverting ileostomy at 1-year follow-up	12 months after surgery
Secondary	Late pelvic collections	Presence of pelvic collections detected at longer follow-up intervals	up to 60 days after surgery
Secondary	Small bowel obstruction	Mechanical small bowel obstruction	up to 60 days after surgery
Secondary	Quality of life associated with a drain	Visual Analogue Scale 0-10 (higher score means better outcome) score of postoperative pain and wound complaints	30 days postoperatively
Secondary	Any complications associated with drain removal after surgery	Safety of drain removal after surgery	up to 60 days after surgery