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Completed

NCT Number: NCT03698604

Total Laparoscopic Hysterectomy Versus Total Abdominal Hysterectomy in Women With Endometrial Neoplasia

The aim of this study is to compare operative time between total laparoscopy hysterectomy with bilateral salpingoophrectomy (TLH+BSO) versus total abdominal hysterectomy and bilateral salpingooophorectomy (TAH+BSO) in women with uterine neoplasia.

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Key information

Conditions

Hysterectomy Laparoscopy

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams Maternity Hospital

Cairo, Egypt

About this study

Research Questions:

Is total laparoscopic hysterectomy associated with similar operative operative time as total abdominal hysterectomy and bilateral salpingoophrectomy in women with uterine neoplasia?

Research Hypothesis:

In women with uterine neoplasia TLH with BSO may be similar to TAH with BSO as regard operative time.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

The presence of perimenopausal bleeding

  • Early stage endometrial carcinoma.
  • Endometrial hyperplasia with/without atypia.

Exclusion criteria

  • Obese patients i.e., BMI< 29 k.g/m2.
  • Patients unfit for laparoscopy as patients with cardio-pulmonary compromise.
  • Presence of adnexal mass.
  • End stage endometrial carcinoma stage 3 & 4.

Treatment and study plan

Hysterectomy

Procedure

Total Laparoscopic Hysterectomy Total Abdominal hysterectomy

Primary outcomes

  1. Operative time

    Time frame: From skin incision till closure of the vault "up to 4 hours".

    Operative time measured in minutes using stopwatch excluding time of concomitant surgical procedures.

Secondary outcomes

  1. Blood loss

    Time frame: From skin incision start until skin suturing is finished "up to 4 hours".

    Intra operative blood loss will be estimated via:

    • Amount of blood in the suction bottle.
    • Estimation will be based on number of soaked gauzes and towels (soaked gauze = 20 ml blood; soaked towel = 150 ml; semi soaked towel = 75 ml).

  2. Blood transfusion

    Time frame: From admission to the hospital until the home discharge "up to 1 week".

    The need to blood transfusion to the patient.

  3. Postoperative pain

    Time frame: 8 hours after the end of operation.

    Assessment of pain intensity using Visual Analog Scale (VAS) which is one-dimensional measure of pain intensity.

    It is a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. The scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100).

  4. Hospital stay

    Time frame: From admission to the hospital until the home discharge "up to 1 week".

    Hospital stay duration in days.

  5. Incidence of operative complications

    Time frame: During operation.

    The need for laparotomy, and bowel or bladder or ureteric injury.

  6. Incidence of postoperative complications

    Time frame: Up to 1 week postoperative.

    Morbidities e.g.:

    • Vaginal vault hematoma or pelvic hematoma or abscess.
    • Surgical site infection.
    • Urinary tract infection.
    • Need for post-operative blood transfusion.
    • Postoperative bowel or urinary tract complications.

Sponsors and collaborators

Lead sponsor

Ain Shams Maternity Hospital

Other

Registry information

Official study title

Total Laparoscopic Hysterectomy Versus Total Abdominal Hysterectomy in Women With Endometrial Neoplasia; Randomized Controlled Clinical Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 9, 2018
Registry last updated
Oct 9, 2018

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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