Hysterectomy, Benign Uterine DiseasesNCT07308197
Effect of Posterior Colpotomy First Technique on the Vaginal Length During Total Abdominal Hysterectomy
A study testing Abdominal hysterectomy in people with Hysterectomy, Benign Uterine Diseases, run by Cairo University at 1 site in Egypt.
Trial summary
the same surgeon performed all of the procedures using the same method. A lower midline or Pfannestiel incision is the first step in the complete abdominal hysterectomy procedure. They clamp, cut, and ligate the top pedicles. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Hysterectomy, Benign Uterine Diseases
- What is being tested?
- Abdominal hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Mar 2023to 16 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 40 - 65 years
- sexually active
- BMI of 25-40 kg/m2
- had a fresh abdomen
- had a benign reason for a hysterectomy (multiple fibroid uterus, adenomyosis, or endometrial hyperplasia).
Who cannot join
- Patients who had vaginal and uterine prolapse,
- subtotal hysterectomy,
- caesarean hysterectomy in patients with major obstetric hemorrhage (placenta previa, accreta-increta-percreta, uncontrolled postpartum hemorrhage)
- malignant indications of total abdominal hysterectomy (uterine and cervical carcinoma)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of (Posterior Colpotomy First) Technique on the Vaginal Length During Total Abdominal Hysterectomy
the same surgeon performed all of the procedures using the same method. A lower midline or Pfannestiel incision is the first step in the complete abdominal hysterectomy procedure. They clamp, cut, and ligate the top pedicles. The cardinal and uterosacral ligaments were dissected, the wide ligament's leaves were cut, the bladder was carefully lowered, and the uterine vessels were skeletonized, cut, and tied. Group A (traditional technique): the surgeon makes a circumferential incision after initially entering the front vaginal wall. The surgeon performs a circumferential colpotomy at the topmost section of the vagina using the Group B (posterior colpotomy first) approach, entering the vagina via the posterior wall at the uppermost part of the uterosacral ligaments, followed by the left lateral fornix.
Reconstruction of the pelvic floor to ensure hemostasis and good pelvic support. The operative time was assessed by calculating the time between vaginal cuff opening and suturing after uterine artery ligation, As point D on the POP-Q system is omitted after hysterectomy, point C level was reassessed 2 weeks postoperative.
Read the detailed description
the same surgeon performed all of the procedures using the same method. A lower midline or Pfannestiel incision is the first step in the complete abdominal hysterectomy procedure. They clamp, cut, and ligate the top pedicles. The cardinal and uterosacral ligaments were dissected, the wide ligament's leaves were cut, the bladder was carefully lowered, and the uterine vessels were skeletonized, cut, and tied. Group A (traditional technique): the surgeon makes a circumferential incision after initially entering the front vaginal wall. The surgeon performs a circumferential colpotomy at the topmost section of the vagina using the Group B (posterior colpotomy first) approach, entering the vagina via the posterior wall at the uppermost part of the uterosacral ligaments, followed by the left lateral fornix.
Reconstruction of the pelvic floor to ensure hemostasis and good pelvic support. The operative time was assessed by calculating the time between vaginal cuff opening and suturing after uterine artery ligation, As point D on the POP-Q system is omitted after hysterectomy, point C level was reassessed 2 weeks postoperative.
Total vaginal shortening (TVS) and vaginal shortening ratio (VSR) were calculated according to the formulas given below.
TVS=Preoperative VL-Postoperative VL at 3 months. VSP=Preoperative VL-Postoperative VL at 3 months\ Preoperative VL*100
- Conditions
- Hysterectomy, Benign Uterine Diseases
- Being tested
- Abdominal hysterectomy
- Keywords
- hystrectomy, posterior colopotomy, Vaginal length
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal hysterectomyProcedure or surgery
A lower midline or Pfannestiel incision is the first step in the complete abdominal hysterectomy procedure. They clamp, cut, and ligate the top pedicles. The cardinal and uterosacral ligaments were dissected, the wide ligament's leaves were cut, the bladder was carefully lowered, and the uterine vessels were skeletonized, cut, and tied
| Study group | Role | What they receive |
|---|---|---|
| Group A (Classic technique): | Active comparator | the surgeon makes a circumferential incision after initially entering the front vaginal wall. The surgeon performs a circumferential colpotomy at the topmost section of the vagina Receives: Procedure: Abdominal hysterectomy |
| Group B (posterior colpotomy first) approach | Active comparator | entering the vagina via the posterior wall at the uppermost part of the uterosacral ligaments, followed by the left lateral fornix Receives: Procedure: Abdominal hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total vaginal length
calculated according to the formula TVS=Preoperative VL-Postoperative VL
Measured: after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start30 Mar 2023
- Primary completion25 Mar 2024
- Study completion16 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hysterectomy, Benign Uterine DiseasesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A lower midline or Pfannestiel incision is the first step in the complete abdominal hysterectomy procedure. They clamp, cut, and ligate the top pedicles. The cardinal and uterosacral ligaments were dissected, the wide ligament's leaves were cut, the bladder was carefully lowered, and the uterine vessels were skeletonized, cut, and tied.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed Maged, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308197
- Sponsor's protocol ID
- 367
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Farid MN, Hammad BM, Saad H, Abdelfattah AA, Maged AM, Soliman MR. The value of posterior colpotomy first technique on the vaginal length during total abdominal hysterectomy. BMC Womens Health. 2026 May 1;26(1):232. doi: 10.1186/s12905-026-04476-1.
PubMed 42063059
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of (Posterior Colpotomy First) Technique on the Vaginal Length During Total Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT07308197
- Acronym / sponsor ID
- 367
- Conditions
- Hysterectomy, Benign Uterine Diseases
- Keywords
- hystrectomy, posterior colopotomy, Vaginal length
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 25 Mar 2024 (actual)
- Study completion
- 16 Sep 2024 (actual)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the same surgeon performed all of the procedures using the same method. A lower midline or Pfannestiel incision is the first step in the complete abdominal hysterectomy procedure. They clamp, cut, and ligate the top pedicles. The cardinal and uterosacral ligaments were dissected, the wide ligament's leaves were cut, the bladder was carefully lowered, and the uterine vessels were skeletonized, cut, and tied. Group A (traditional technique): the surgeon makes a circumferential incision after initially entering the front vaginal wall. The surgeon performs a circumferential colpotomy at the topmost section of the vagina using the Group B (posterior colpotomy first) approach, entering the vagina via the posterior wall at the uppermost part of the uterosacral ligaments, followed by the left lateral fornix.
Reconstruction of the pelvic floor to ensure hemostasis and good pelvic support. The operative time was assessed by calculating the time between vaginal cuff opening and suturing after uterine artery ligation, As point D on the POP-Q system is omitted after hysterectomy, point C level was reassessed 2 weeks postoperative.
Detailed description
the same surgeon performed all of the procedures using the same method. A lower midline or Pfannestiel incision is the first step in the complete abdominal hysterectomy procedure. They clamp, cut, and ligate the top pedicles. The cardinal and uterosacral ligaments were dissected, the wide ligament's leaves were cut, the bladder was carefully lowered, and the uterine vessels were skeletonized, cut, and tied. Group A (traditional technique): the surgeon makes a circumferential incision after initially entering the front vaginal wall. The surgeon performs a circumferential colpotomy at the topmost section of the vagina using the Group B (posterior colpotomy first) approach, entering the vagina via the posterior wall at the uppermost part of the uterosacral ligaments, followed by the left lateral fornix.
Reconstruction of the pelvic floor to ensure hemostasis and good pelvic support. The operative time was assessed by calculating the time between vaginal cuff opening and suturing after uterine artery ligation, As point D on the POP-Q system is omitted after hysterectomy, point C level was reassessed 2 weeks postoperative.
Total vaginal shortening (TVS) and vaginal shortening ratio (VSR) were calculated according to the formulas given below.
TVS=Preoperative VL-Postoperative VL at 3 months. VSP=Preoperative VL-Postoperative VL at 3 months\ Preoperative VL*100
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A lower midline or Pfannestiel incision is the first step in the complete abdominal hysterectomy procedure. They clamp, cut, and ligate the top pedicles. The cardinal and uterosacral ligaments were dissected, the wide ligament's leaves were cut, the bladder was carefully lowered, and the uterine vessels were skeletonized, cut, and tied.
| Arm | Type | Receives |
|---|---|---|
| Group A (Classic technique): | Active comparator | Procedure: Abdominal hysterectomythe surgeon makes a circumferential incision after initially entering the front vaginal wall. The surgeon performs a circumferential colpotomy at the topmost section of the vagina |
| Group B (posterior colpotomy first) approach | Active comparator | Procedure: Abdominal hysterectomyentering the vagina via the posterior wall at the uppermost part of the uterosacral ligaments, followed by the left lateral fornix |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages 40 - 65 years
- sexually active
- BMI of 25-40 kg/m2
- had a fresh abdomen
- had a benign reason for a hysterectomy (multiple fibroid uterus, adenomyosis, or endometrial hyperplasia).
Key exclusion criteria (4 listed)
- Patients who had vaginal and uterine prolapse,
- subtotal hysterectomy,
- caesarean hysterectomy in patients with major obstetric hemorrhage (placenta previa, accreta-increta-percreta, uncontrolled postpartum hemorrhage)
- malignant indications of total abdominal hysterectomy (uterine and cervical carcinoma)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal hysterectomyA lower midline or Pfannestiel incision is the first step in the complete abdominal hysterectomy procedure. They clamp, cut, and ligate the top pedicles. The cardinal and uterosacral ligaments were dissected, the wide ligament's leaves were cut, the bladder was carefully lowered, and the uterine vessels were skeletonized, cut, and tied | Procedure or surgery | Group A (Classic technique):, Group B (posterior colpotomy first) approach |
Primary outcome
Total vaginal length
Time frame: after 3 months
calculated according to the formula TVS=Preoperative VL-Postoperative VL
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Derived from this study: PubMed 42063059Farid MN, Hammad BM, Saad H, Abdelfattah AA, Maged AM, Soliman MR. The value of posterior colpotomy first technique on the vaginal length during total abdominal hysterectomy. BMC Womens Health. 2026 May 1;26(1):232. doi: 10.1186/s12905-026-04476-1.
- Individual participant dataSharing planned: Undecided
Related trials for Hysterectomy, Benign Uterine Diseases
Recruiting
vNOTES Versus Vaginal Hysterectomy for Benign Gynecologic Indications
Hysterectomy, Benign Uterine Diseases
Not yet recruitingObservational study
Robotic Minimally Invasive Benign Hysterectomy Post-market Clinical Study With the DEXTER Robotic System
Hysterectomy, Benign Uterine Diseases
Recruiting
Deep Neuromuscular Blockade and a Low-Residue Diet for the Surgical Field in vNOTES Hysterectomy
Leiomyoma, Uterine, Benign Gynecological Disease
Enrolling by invitation
Effect of Abdominal Ice Pack After vNOTES Hysterectomy
Hysterectomy, Benign Uterine Diseases, Hysterectomy, Vaginal
Active, not recruitingObservational study
The Learning Curve of a Gynecology and Obstetrics Resident Performing Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES) Hysterectomy in a University Hospital
Abnormal Uterine Bleeding, Unspecified, Benign Gynecological Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Maged principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal hysterectomy in people with Hysterectomy, Benign Uterine Diseases, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total vaginal length (time frame: after 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07308197, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.