Feasibility, Safety and Outcome of Transrectal Hybrid-NOTES Anterior Resection

Colon Adenoma Clinical Trial

Official title:

Feasibility, Safety and Outcome of Transrectal Hybrid-NOTES Anterior Resection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01992406
• Other study ID #: TRANSRECTAL
• Status: Recruiting
• Phase: N/A
• First received: November 12, 2013
• Last updated: July 15, 2015
• Start date: November 2013

Study information

• Verified date: July 2015
• Source: Cantonal Hosptal, Baselland
• Contact: Daniel C Steinemann, MD
• Phone: +41 61 436 36 36
• Email: daniel.steinemann[@]ksbl.ch
• Is FDA regulated: No
• Health authority: Switzerland: Laws and standards
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Natural orifice transluminal endoscopic surgery has become an important topic. NOTES access routes give the opportunity to reduce surgical access trauma leading to a more painless surgery and enhancing a fast postoperative recovery. Experience with transvaginal laparoscopic cholecystectomy and transvaginal anterior resection for diverticulitis show that such NOTES procedures are feasible and safe. The complication rate to conventional laparoscopic procedures is similar. Since transvaginal access is impossible in men, an alternative route is missing. There are experimental studies and small case series reporting the feasibility of transrectal anterior resection. However any prospective feasibility study demonstrating the safety of the procedure and functional outcomes (sphincter function) are missing. This study investigates the feasibility, practicability, safety and subjective as well as functional outcome of transrectal hybrid-NOTES anterior resection.

Description:

Primary endpoint:

To demonstrate in a prospective cohort study the feasibility (specimen extraction through rectum possible to perform or not), safety (complications graded according to Clavien-Dindo) and postoperative outcome (gastrointestinal quality of life questionnaire and anal sphincter manometry) of routine hybrid-NOTES transrectal anterior resection for benign indication in men and women.

Secondary endpoints:

• quality of life 6 months after surgery

• continence 6 months after surgery

• pain postoperative

• complication rate

• duration of procedure

• lengh of stay

Hypothesis:

The investigators expect specimen extraction through the rectum to be feasible in 80% of cases (in the others an alternative mini-laparotomy has to be performed).

study design: This is an open cohort study on 60 patients. The patients are included before surgery and baseline parameters are put in a registry. There are clinical controls 6 weeks, 3 and 6 months postoperative. 3 and 6 months postoperative as well as preoperative a anorectal manometry is performed.

Inclusion criteria:

• benign indication for left sided colectomy.

exclusion criteria:

• age <18 years

• patient unable to understand informed consent or missing informed consent

• emergency surgery

power calculation: A feasibility of 80% with a precision of 15% is estimated. Given a 5% drop out rate 36 patients are to be included in the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• benign indication for left sided colectomy

Exclusion Criteria:

• age below 18 years

• unable to understand informed consent of missing informed consent

• emergency surgery

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colon Adenoma
• Diverticulitis
• Diverticulum
• Rectal Prolapse
• Sigmoid Diverticulitis
• Sigmoid Diverticulosis

Locations

Country	Name	City	State
Switzerland	Kantonsspital Baselland, Department of Surgery, Bruderholz	Bruderholz

Sponsors (1)

Lead Sponsor	Collaborator
Cantonal Hosptal, Baselland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transanal specimen extraction possible or not	Feasibility to remove the specimen (sigmoid colon) through the rectum/anus. If this is not possible during surgery (due to bulky specimen or narrow pelvis) an alternative mini-laparotomy has to be performed.	at surgery	No
Secondary	Number of Participants with postoperative complications (and severity of complications according Clavien-Dindo)	Postoperative complications are recorded and graded according to Clavien-Dindo classification. Complication rates and especially occurence of anastomotic leakage and pelvic sepsis will be compared to the literature of current techniques.	up to 6 weeks postoperative	Yes
Secondary	continence 6 months postoperative		6 months postoperative	No
Secondary	quality of life		6 months postoperative	No