Laparoscopic Transvaginal Hybrid Anterior Resection: a Prospective Data Collection

Sigmoid Diverticulitis (Hinchey I and II) Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01043731
• Other study ID #: EKSG09/151/2B
• Status: Completed
• Phase: N/A
• First received: January 6, 2010
• Last updated: December 9, 2010
• Start date: September 2008
• Est. completion date: November 2010

Study information

• Verified date: July 2010
• Source: Cantonal Hospital of St. Gallen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Department of surgery	St. Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Cantonal Hospital of St. Gallen

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and safety of the transvaginal operation		30 days	Yes
Secondary	Long-term life quality and sexual dysfunction		3 year	Yes