Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery

NCT07772076 | Not Yet Recruiting

• 1 other identifier: CET 111-2026
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational registry aims to systematically collect preoperative, intraoperative, and postoperative clinical data from patients undergoing surgery for benign gynecological conditions. The main goal is to evaluate clinical outcomes, surgical approaches, and complications in real-world clinical practice.

Conditions

Benign Gynecological Disease; Uterine Fibroids; Endometriosis; Adenomyosis; Pelvic Adhesions; Ovarian Cyst Benign; Salpingitis; Polyp Endometrium; Ectopic Pregnancy

Keywords

Gynecological Surgery; Perioperative Data; Laparoscopy; uterine fibroids; endometriosis; Registry; Uterine Myoma; Pelvic Pain; Surgical Outcomes; Hysteroscopy; Laparotomy; Perioperative Care; Postoperative Complications; Real-World Evidence

Outcome Measures

Primary Outcomes (1)

• Intraoperative and Postoperative Complications

  Incidence and severity of intraoperative and postoperative complications categorized according to the Clavien-Dindo classification

  perioperatively/periprocedurally

Secondary Outcomes (4)

• Operative Time

  perioperatively/periprocedurally

• Surgical Blood Loss

  perioperatively/periprocedurally

• Length of Hospital Stay

  up to 30 days

• Post-operative Pain Score

  perioperatively/periprocedurally

Study Arms (1)

Gynecological Surgery Cohort

Women with indication for elective benign gynecological surgery undergoing standard clinical surgical procedures (laparoscopy, laparotomy, vaginal, robotic, hysteroscopy, vNOTES).

Procedure: Standard Surgical Procedures for Benign Gynecological Conditions

Interventions

Standard Surgical Procedures for Benign Gynecological Conditions PROCEDURE

Patients undergo standard-of-care elective surgery for benign gynecological conditions according to routine clinical practice, including laparoscopy, laparotomy, vaginal surgery, robotic-assisted surgery, operative hysteroscopy, or vNOTES. The choice of procedure is determined solely by clinician judgment and standard medical indication. Data on surgical technique, intraoperative parameters, and perioperative outcomes are recorded prospectively.

Gynecological Surgery Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women scheduled to undergo elective surgery for benign gynecological conditions (including uterine fibroids, adenomyosis, endometriosis, pelvic growths, pelvic adhesions, cervical-vulvar-vaginal dysplasia, endometrial hyperplasia, infertility, pelvic inflammatory disease, intracavitary polyps/myomas, female genital malformations, or genital prolapse) at the Gynecology Unit of IRCCS San Raffaele Hospital.

You may qualify if:

• Age \>= 18 years
• Diagnosis of benign gynecological disease (e.g., uterine fibroids, endometriosis, pelvic neoplasm, endometrial polyp, endometrial hyperplasia, cervical dysplasia, pelvic adhesions, isthmocele, genital prolapse, adenomyosis, female genital malformations, pelvic inflammatory disease)
• Indication for elective benign gynecological surgery
• Signed written informed consent for data collection

You may not qualify if:

• Age \< 18 years
• Suspected or confirmed malignant gynecological disease
• Current pregnancy
• Emergency / unscheduled surgical procedure
• No indication for surgery
• Refusal or inability to provide signed informed consent

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele - U.O. Ginecologia e Ostetricia

Milan, Milano, Italy

Location

MeSH Terms

Conditions

Leiomyoma; Endometriosis; Adenomyosis; Salpingitis; Pregnancy, Ectopic; Myofibroma; Pelvic Pain; Postoperative Complications

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Diseases; Fallopian Tube Diseases; Adnexal Diseases; Pelvic Inflammatory Disease; Pregnancy Complications; Neoplasms, Connective Tissue; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Central Study Contacts

Massimo Candiani, MD, Prof

CONTACT

+39 02-26432653; candiani.massimo@hsr.it

Giorgio Candotti, MD

CONTACT

candotti.giorgio@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 19, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2036
• Study Completion (Estimated): September 1, 2039
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)