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NCT Number: NCT07772076

Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery

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.

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Key information

Conditions

Benign Gynecological Disease Adenomyosis Adnexal Diseases Connective Tissue Diseases Ectopic Pregnancy Endometriosis Fallopian Tube Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Leiomyoma Myofibroma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Neurologic Manifestations Ovarian Cyst Benign Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Adhesions Pelvic Inflammatory Disease Pelvic Pain Polyp Endometrium Postoperative Complications Pregnancy Complications Pregnancy, Ectopic Salpingitis Signs and Symptoms Skin and Connective Tissue Diseases Urogenital Diseases Uterine Diseases Uterine Fibroids

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

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

Milan, Milano, Italy

Location contact

Massimo Candiani, MD, Professor

CONTACT

[email protected]

+39 02-26432653

Massimo Candiani, MD, Professor

PRINCIPAL_INVESTIGATOR

About this study

Benign gynecological diseases frequently require surgical intervention via laparoscopy, laparotomy, vaginal, or robotic approaches. This single-center registry prospectively records baseline patient characteristics, surgical parameters, intraoperative complications, and postoperative outcomes up to 30 days post-surgery (with standard clinical follow-up up to 3 years). The collected data will enable descriptive and exploratory comparative evaluations to optimize perioperative care and surgical management.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Intraoperative and Postoperative Complications

    Time frame: perioperatively/periprocedurally

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

Secondary outcomes

  1. Operative Time

    Time frame: perioperatively/periprocedurally

    Total duration of the surgical procedure measured from skin incision to skin closure, reported in minutes

  2. Surgical Blood Loss

    Time frame: perioperatively/periprocedurally

    Estimated total intraoperative blood loss measured in milliliters (mL)

  3. Length of Hospital Stay

    Time frame: up to 30 days

    Total duration of hospitalization from admission for surgery to hospital discharge, reported in days

  4. Post-operative Pain Score

    Time frame: perioperatively/periprocedurally

    Post-operative pain level assessed using the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain severity

Study contacts

Contact information is provided by the study sponsor or research team.

Giorgio Candotti, MD

CONTACT

[email protected]

Massimo Candiani, MD, Prof

CONTACT

[email protected]

+39 02-26432653

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

Prospective Observational Registry on the Collection of Perioperative Clinical Data in Gynecology

Acronym: OPGYNBEN

Important dates

Study start
2026
Primary completion
2036
Study completion
2039
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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