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Laparoscopic Transvaginal Hybrid Anterior Resection: a Prospective Data Collection

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01043731
Enrollment
45
Registered
2010-01-07
Start date
2008-09-30
Completion date
2010-11-30
Last updated
2010-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

PROCEDURELaparoscopic 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.

Sponsors

Cantonal Hospital of St. Gallen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Feasibility and safety of the transvaginal operation30 days

Secondary

MeasureTime frame
Long-term life quality and sexual dysfunction3 year

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026