NCT01043731

Laparoscopic Transvaginal Hybrid Anterior Resection: a Prospective Data Collection

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 45 (estimated)
• Sponsor: Cantonal Hospital of St. Gallen · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Sigmoid Diverticulitis (Hinchey I and II)
• Sigmoid Diverticulosis With Two or More Attacks of Diverticulitis

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic transvaginal hybrid anterior resection	Transvaginal Hybrid Anterior Resection: three 5mm trocars are placed transabdominally (one trans-umbilical, the other two in the lower abdomen). Identification of the inferior mesenteric vein and artery. Clipping of the vein. Then placement of a 12mm trocar through the posterior fornix of the vagina for stapling of the inferior mesenteric artery. After mobilisation of the colon descendens and the splenic flexure stapling of the proximal rectum through the 12mm trocar placed vaginally. Afterwards the colpotomy is performed and the mobilised left hemi-colon is extracted transvaginally. The proximal colonic resection is performed extracorporeally in the conventional fashion with placement of a purse-string suture and insertion of the circular stapling anvil into the proximal end of the bowel. The bowel is then replaced into the abdominal cavity. The colpotomy is then closed. A circular stapler is inserted transanally and the end-to-end anastomosis is performed.

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2010-01-07
• Last updated: 2010-12-10

Locations

1 site across 1 country: Switzerland