Comparison of teaching efficacy between laparoscopic intraoperative feedback and supervisor feedback for pelvic examination training in endometriosis diagnosis
| ISRCTN | ISRCTN32847897 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32847897 |
| Sponsor | First Affiliated Hospital Zhejiang University |
| Funder | Department of Education of Zhejiang Province |
- Submission date
- 29/06/2026
- Registration date
- 29/06/2026
- Last edited
- 29/06/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jing Shu
Scientific, Public, Principal investigator
Scientific, Public, Principal investigator
Center for Reproductive Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
310003
China
 ORCID ID |
0000-0003-0398-2188 |
|---|---|
| Phone | +86 0571-87235027 |
| shu_jing@zju.edu.cn |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Non-randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Gynecological medical education training research, comparing the efficiency of two clinical skill feedback training modes for endometriosis pelvic examination |
| Scientific title | Laparoscopic intraoperative visual feedback versus conventional supervisor verbal feedback for training inexperienced gynecology trainees to perform pelvic examination for endometriosis diagnosis: a single-center prospective comparative learning curve analysis |
| Study objectives | To compare the improvement of endometriosis pelvic examination diagnostic accuracy between laparoscopic intraoperative visual feedback training and traditional supervisor verbal feedback training among inexperienced gynecology trainees. |
| Ethics approval(s) |
Approved 18/05/2025, Clinical Research Ethics Committee of the First Affiliated Hospital, Zhejiang University School of Medicine (79 Qingchun Road, Hangzhou, 310003, China; 0571-87233418; zyiitlunli@163.com), ref: 2025-944 |
| Health condition(s) or problem(s) studied | Women with clinical suspicion of endometriosis during infertility evaluation requiring laparoscopy |
| Intervention | This is a single-center prospective comparative educational intervention study. Six inexperienced gynecology residents/junior attending physicians without specialized endometriosis examination experience are evenly divided into two parallel training groups, each trainee completes 30 standardized pelvic examinations on infertile patients with suspected endometriosis requiring laparoscopic surgery. Group 1 (Laparoscopic intraoperative feedback group, n=3 trainees, total 90 patients): Each patient receives preoperative standardized pelvic examination by trainee; during laparoscopic operation under anesthesia, trainee repeats sterile bimanual palpation and directly compares tactile palpation findings with real intraoperative pelvic lesion visualization to obtain real-time visual feedback after each case. Group 2 (Supervisor verbal feedback group, n=3 trainees, total 90 patients): Trainee completes independent preoperative pelvic examination, reports palpation findings to senior attending supervisor with over 15-year laparoscopic experience; supervisor provides only verbal correction and guides repeated palpation for inconsistent anatomical sites, no intraoperative visual reference is available. For every patient, 8 binary anatomical judgments are recorded, including vesicouterine pouch, bilateral adnexa, bilateral uterosacral ligaments, posterior fornix, obliteration of Douglas pouch and rectum. Laparoscopic intraoperative lesions are set as gold standard reference. LC-CUSUM analysis is used to calculate individual learning curve, with successful case defined as ≥6 correct judgments out of 8 anatomical sites (accuracy ≥75%). All patients complete follow-up until laparoscopic lesion confirmation, no long-term postoperative follow-up is required. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 15/03/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Female |
| Target sample size at registration | 180 |
| Total final enrolment | 180 |
| Key inclusion criteria | 1. Reproductive-aged women with infertility requiring laparoscopic surgery 2. Clinical suspicion of endometriosis before operation 3. Agree to receive standardized pelvic examination by gynecology trainee 4. Voluntarily sign written informed consent to participate in this educational research |
| Key exclusion criteria | 1. Severe pelvic malformation unable to complete pelvic examination 2. Refuse pelvic examination by trainee physicians 3. Decline to join this clinical training research |
| Date of first enrolment | 20/05/2025 |
| Date of final enrolment | 26/02/2026 |
Locations
Countries of recruitment
- China
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
29/06/2026: Study’s existence confirmed by the Clinical Research Ethics Committee of the First Affiliated Hospital, Zhejiang University School of Medicine, China.
