Laparoscopic Transvaginal Hybrid Anterior Resection: a Prospective Data Collection

Cantonal Hospital of St. Gallen

Status: Completed

Conditions: Sigmoid Diverticulitis (Hinchey I and II); Sigmoid Diverticulosis With Two or More Attacks of Diverticulitis

Treatments: Procedure: Laparoscopic transvaginal hybrid anterior resection

Study type: Observational

Funder types: Other

Identifiers

NCT01043731

EKSG09/151/2B

Details and patient eligibility

About

Transvaginal hybrid procedures are of interest as an available NOTES-Procedure for the clinical routine. Few authors have demonstrated the feasibility and safety of such procedures (e.g. cholecystectomy) in selected patient collectives. In 2008 Lacy at al. published the experience with a transvaginal sigmoidectomy as a first in human report. The aim of this prospective data collection is to evaluate the feasibility and safety of the transvaginal hybrid anterior resection in the clinical routine.

Therefore all patients giving the informed consent to the transvaginal hybrid anterior resection will be included and assessed concerning feasibility to perform the transvaginal approach and complete the operation transvaginally.

Enrollment: 45 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• given informed consent
• sigmoid diverticulosis (two or more attacks)
• sigmoid diverticulitis (Hinchey I and II)

Exclusion criteria

• ASA IV
• emergency surgery
• liver-malfunction or coagulation disorders
• acute diverticulitis (Hinchey III and IV)
• malignancy
• acute vaginal infection
• refusal of mandatory preoperative gynecological examination
• pregnancy
• endometriosis
• previous surgery of colon and rectum
• strongly retroflexed uterus
• acute pelvic disorders, infection

Trial design

45 participants in 1 patient group

Ginven indication for laparoscopic anterior resection

Treatment:

Procedure: Laparoscopic transvaginal hybrid anterior resection