Abdominal keyhole surgery with spinal anesthesia
| ISRCTN | ISRCTN56613886 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56613886 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | ESTHER |
| Funder | ESTHER Switzerland – Network for the promotion of Institutional Health Partnerships (IHP) |
- Submission date
- 30/10/2020
- Registration date
- 01/07/2024
- Last edited
- 03/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Pelvic surgery is performed with the patient in the Trendelenburg position (lying on the operating table which is angled so that the head is lower than the feet) and with high intraabdominal CO₂ pressure in order to move the intestines out of the surgical field and to create an optimal view for the surgical team.
The aim of this study is to assess the effectiveness and safety of laparoscopic surgery with spinal anesthesia in the Trendelenburg position with different pressures of CO₂. What is the best protocol in terms of risk and comfort for the patient and the surgeon?
Who can participate?
Women due to undergo laproscopic surgery
What does the study involve?
The surgery is carried out as usual. Different pressures of CO₂ are used to investigate the effect on ease of performing the surgery and the level of risk to the patient.
What are the possible benefits and risks of participating?
None
Where is the study run from?
Medline Clinics (Uzbekistan)
When is the study starting and how long is it expected to run for?
December 2018 to October 2020
Who is funding the study?
ESTHER Switzerland – Network for the promotion of Institutional Health Partnerships (IHP)
Who is the main contact?
1. Dr Attila Major
majorattila@outlook.fr
2. Dr Kudrat Jumaniyozov
wittness93@gmail.com
3. Olimjon Saidmamatov
saidolimjon@gmail.com
Contact information
Scientific
Femina gynecology centre
Rue Emile-Yung 1
Geneva
1205
Switzerland
 ORCID ID |
0000-0002-1459-2727 |
|---|---|
| Phone | +41 (0)795222440 |
| majorattila@outlook.fr |
Scientific
Urgench Branch of Tashkent Medical Academy, 14, H.Olimjon str
Urgench
220100
Uzbekistan
| ORCID ID |
0000-0001-5668-3144 |
|---|---|
| Phone | +998919853223 |
| wittness93@gmail.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective observational study |
| Secondary study design | Case-control study |
| Study type | Participant information sheet |
| Scientific title | Laparoscopic surgery with spinal anesthesia: a prospective observational study |
| Study objectives | The primary objective is to evaluate the feasibility of laparoscopic surgery of the pelvic organs under loco-regional anesthesia. Patient and surgeon comfort are analyzed by using different parameters of the laparoscopic procedure (degree of Trendelenburg inclinision, pressure of CO2-pneumoperitoneum, type of operation, length of operation). Side effects will be recorded. The secondary objective is to analyse the recovery of the patient after surgery. |
| Ethics approval(s) | Approved 02/12/2018, Ethical Committee at Tashkent Medical Academy, Urgench branch, Uzbekistan (14, H.Olimjon str, Urgench, Khorezm region, 220100, Uzbekistan; +998 (0)995649170; no email provided), ref: 01/2016 |
| Health condition(s) or problem(s) studied | Gynecological diseases in the pelvis |
| Intervention | Laparoscopic surgery was performed for pelvic diseases using spinal anesthesia and with the patient in the Trendelenburg position, using different CO₂ pressures for pneumoperitoneum. Without or with very low CO₂ pressures the uterus was pushed with a cervical manipulator forceps towards the abdominal wall in order to view the organs of the pelvis. No additional medicine was used intravenously. Pneumoperitoneum was generated with CO₂ gas between 4 to 14 mmHg. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Measured using a survey before, during and post surgery: |
| Key secondary outcome measure(s) |
Measured using self-report on a 0–10 scale (0=minimum, 10=maximum impairment) before, during and post surgery: |
| Completion date | 30/10/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 100 |
| Total final enrolment | 93 |
| Key inclusion criteria | 1. Women who will undergo laparoscopic surgery in the lower abdomen 2. Minimum follow up of 6 months |
| Key exclusion criteria | 1. Contraindication for loco-regional anesthesia 2. Do not consent to complete the questionnaire |
| Date of first enrolment | 09/01/2019 |
| Date of final enrolment | 23/05/2019 |
Locations
Countries of recruitment
- Uzbekistan
Study participating centre
Urgench
220100
Uzbekistan
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 14/06/2024 | 28/08/2024 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
03/09/2024: Study contact updated.
28/08/2024: Publication reference added.
24/11/2020: Trial's existence confirmed by Ethical Committee at Tashkent Medical Academy.
