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Laparoscopic Transvaginal Hybrid Anterior Resection: a Prospective Data Collection

C

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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