HysterectomyLAVHNCT03548831
Comparative Study of LAVH and Minilaparotomy Hysterectomy
An observational study of Hysterectomy and Minimal Invasive Surgery, run by Manipal University.
Trial summary
Minilaparotomy hysterectomy (MLH) relies on the simplicity of traditional open technique of abdominal hysterectomy, imparts cosmesis and faster recovery of laparoscopic hysterectomy yet avoids the long learning curve, cost of expensive setup and instrumentation associated with the minimally invasive approaches namely… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hysterectomy, Minimal Invasive Surgery, Benign Gynecologic Neoplasm
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Jun 2016
- Phase
- Observational
- 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 Any age
- Women only
- Child, Adult, Older adult
Study population: Women who are admitted in the Department of OBG, Kasturba Hospital, Manipal for hysterectomy for benign gynaecological disorders with non descent uterus.
Who may be able to join
- Non descent uterus with benign gynaecological conditions
Who cannot join
- Uterine size > 20 weeks
- Minilaparotomy was contraindicated in patients where severe adhesions might exist eg -
- Endometriosis
- Previous pelvic inflammatory disease
- Patients with one or more contraindications for LAVH were excluded -
- Cardiac or respiratory morbidity contraindicating laparoscopy
- Frozen pelvis
- Cervix flushed with vagina
About this study
Official title: Comparative Study of Laparoscopic Assisted Vaginal Hysterectomy and Minilap Hysterectomy for Benign Gynaecological Conditions
Minilaparotomy hysterectomy (MLH) relies on the simplicity of traditional open technique of abdominal hysterectomy, imparts cosmesis and faster recovery of laparoscopic hysterectomy yet avoids the long learning curve, cost of expensive setup and instrumentation associated with the minimally invasive approaches namely laparoscopy and robotics. In the present study, we tried to ascertain if the results obtained with MLH can be compared to LAVH in terms of its feasibility, intraoperative variables, and complications. The null hypothesis was that both MLH and LAVH are comparable techniques, so where cost and surgeon's experience are the confining issues, patients can be reassured that MLH gives comparable results.
Read the detailed description
Around 600,000 hysterectomies are performed every year in the United States, making hysterectomy the second most common surgery for women, first being cesarean section. Most of the hysterectomies are done for non cancerous conditions. And the most common indication for the same is symptomatic fibroid uterus.
In spite of being the most common gynaecological surgery the route of hysterectomy has always been an issue of debate since early 19th century. In the beginning it started as vaginal hysterectomy which soon was taken over by laparotomy route. With the advent of laparoscopy as the recent minimally invasive route the choices have further increased. Laparoscopic route has prompted the need for development of other forms of hysterectomy which are minimally invasive and are associated with less perioperative morbidity with better postoperative outcomes. Abdominal route includes both conventional and minilaparotomy; laparoscopic route includes both Laparoscopic Assisted Vaginal Hysterectomy (LAVH) as well as Total Laparoscopic Hysterectomy (TLH). Each method has its own advantages and disadvantages. The vaginal route is preferable because it is associated with less perioperative morbidity and faster recovery. Although laparoscopic route offers minimally invasive alternative to abdominal hysterectomy when vaginal route is contraindicated (In case of huge fibroid uterus or patients with pelvic pathology), it has its own drawbacks. The laparoscopic instruments are costly, there is a long learning curve involved in the training, and the operating time with this route is prolonged.
The EVALUATE study suggested that majority of surgeons(67%) preferred abdominal approach as the route of surgery, especially when dealing with pelvic pathology. Hence, minilaparotomy hysterectomy as an alternative minimally invasive surgery method was started. It relies on traditional open techniques and inexpensive instrumentation, making it significantly faster than laparoscopy and easy to perform. Hoffman et al found minilaparotomy hysterectomy procedure effective and safe in non-obese women in whom vaginal approach was contraindicated. Fanfani et al did a retrospective analysis on 252 patients who underwent minilaparotomy hysterectomy and found it to be a feasible route of surgery in benign gynaecological conditions with operative time similar or shorter as compared to vaginal, laparotomy and laparoscopy surgery. Few surgeons have modified the incision depending on the their experience which led to development of Pelosi method of Minilaparotomy Hysterectomy in 2003.
The final choice of the route and method depends on multiple factors which include indication of surgery, size of fibroid, equipments available in the surgical set up, surgeons' expertise, patient's financial background.
All patients followed the same standard pre-operative protocol. All surgeries were performed under general anesthesia with endotracheal intubation. Demographic details that included age, parity, body mass index (BMI), baseline investigations, diagnosis, and co-morbidities, were collated a day prior to the day of surgery. On admission, patients were informed in detail about the operation modalities and the associated complications. Patients along with their relatives were counselled about the advantages and disadvantages of both the surgical methods and the final decision was made on a joint consensus between the surgeon and the patient, following which an informed written consent was obtained.
The aim of the study was to compare the feasibility of two minimally invasive surgical procedures in low resource settings (such as India) - Laparoscopic assisted vaginal hysterectomy (LAVH) and Minilaparotomy hysterectomy (transverse suprapubic incision <7cm).
- Keywords
- Minilaparotomy, Hysterectomy, Laparoscopic assisted vaginal hysterectomy, Benign, Gynaecology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MLH | Minilaparotomy Hysterectomy | |
| LAVH | Laparoscopic Assisted Vaginal Hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of surgery
All surgeries were performed by two gynecologists with an almost equal level of surgical competence.
Measured: Intra operatively
Blood loss
Total amount of blood loss was calculated during both the methods. It was calculated by adding up the mop count (one fully soaked mop ~ 50 ml of blood loss) and the amount of fluid in the suction pump minus the saline used for irrigation.
Measured: Intra operatively
Postoperative pain
There are various methods to score pain. In our study, we used visual analogue scale for the scoring. The pain was scored every 6th hourly for the first 24hrs and thereafter 24th hourly till 72 hrs.
The Visual Analogue Scale (VAS) (Figure 14) is a scoring scale on which the patient rates his/her pain on a scale of 0 to 10, 0 representing no pain and 10 representing excruciating or intolerable pain. The scoring is subjective and gives the patient freedom to choose the intensity of the pain as per their perception.
Measured: Starting from immediate post-operative period till 72 hours.
Secondary outcomes (5)
Weight of uterus
In grams unit
Measured: Intra operatively
Intra-operative complications
Visceral injury such as bladder/ ureter / bowel injury
Measured: Intra-operatively
Conversion rate
Conversion to conventional laparotomy
Measured: Intraoperatively
Post operative complications
Secondary haemorrhage, Urinary Tract Infection, Urinary retention, Wound infection, Thrombo-embolic complications, Febrile morbidity
Measured: Upto 1 month
Duration of hospital stay
In days
Measured: Upto 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study startAug 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manipal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abhilasha Agarwal, Manipal University
- Investigators
- Abhilasha Agarwal, MS, Principal investigator, Manipal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548831
- Sponsor's protocol ID
- IEC 429/2014
- Acronym
- LAVH
- Status last verified
- May 2018
- First submitted
- 16 Apr 2018
- Last updated
- 7 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: All IPD that underlie results in a publication maybe shared after sponsor approval. Present status - undecided.
Publications
Wu JM, Wechter ME, Geller EJ, Nguyen TV, Visco AG. Hysterectomy rates in the United States, 2003. Obstet Gynecol. 2007 Nov;110(5):1091-5. doi: 10.1097/01.AOG.0000285997.38553.4b.
PubMed 17978124Garry R, Fountain J, Brown J, Manca A, Mason S, Sculpher M, Napp V, Bridgman S, Gray J, Lilford R. EVALUATE hysterectomy trial: a multicentre randomised trial comparing abdominal, vaginal and laparoscopic methods of hysterectomy. Health Technol Assess. 2004 Jun;8(26):1-154. doi: 10.3310/hta8260.
PubMed 15215018Hoffman MS, Lynch CM. Minilaparotomy hysterectomy. Am J Obstet Gynecol. 1998 Aug;179(2):316-20. doi: 10.1016/s0002-9378(98)70358-8.
PubMed 9731832Fanfani F, Fagotti A, Longo R, Marana E, Mancuso S, Scambia G. Minilaparotomy in the management of benign gynecologic disease. Eur J Obstet Gynecol Reprod Biol. 2005 Apr 1;119(2):232-6. doi: 10.1016/j.ejogrb.2004.07.040.
PubMed 15808386Pelosi MA 2nd, Pelosi MA 3rd. Pelosi minilaparotomy hysterectomy: a non-endoscopic minimally invasive alternative to laparoscopy and laparotomy. Surg Technol Int. 2004;13:157-67.
PubMed 15744686Agarwal A, Shetty J, Pandey D, Jain G. Feasibility and Compatibility of Minilaparotomy Hysterectomy in a Low-Resource Setting. Obstet Gynecol Int. 2018 Aug 1;2018:8354272. doi: 10.1155/2018/8354272. eCollection 2018.
PubMed 30154857
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Laparoscopic Assisted Vaginal Hysterectomy and Minilap Hysterectomy for Benign Gynaecological Conditions
- ClinicalTrials.gov ID
- NCT03548831
- Acronym / sponsor ID
- LAVH / IEC 429/2014
- Keywords
- Minilaparotomy, Hysterectomy, Laparoscopic assisted vaginal hysterectomy, Benign, Gynaecology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Manipal UniversityUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 7 Jun 2018 (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.
Minilaparotomy hysterectomy (MLH) relies on the simplicity of traditional open technique of abdominal hysterectomy, imparts cosmesis and faster recovery of laparoscopic hysterectomy yet avoids the long learning curve, cost of expensive setup and instrumentation associated with the minimally invasive approaches namely laparoscopy and robotics. In the present study, we tried to ascertain if the results obtained with MLH can be compared to LAVH in terms of its feasibility, intraoperative variables, and complications. The null hypothesis was that both MLH and LAVH are comparable techniques, so where cost and surgeon's experience are the confining issues, patients can be reassured that MLH gives comparable results.
Detailed description
Around 600,000 hysterectomies are performed every year in the United States, making hysterectomy the second most common surgery for women, first being cesarean section. Most of the hysterectomies are done for non cancerous conditions. And the most common indication for the same is symptomatic fibroid uterus.
In spite of being the most common gynaecological surgery the route of hysterectomy has always been an issue of debate since early 19th century. In the beginning it started as vaginal hysterectomy which soon was taken over by laparotomy route. With the advent of laparoscopy as the recent minimally invasive route the choices have further increased. Laparoscopic route has prompted the need for development of other forms of hysterectomy which are minimally invasive and are associated with less perioperative morbidity with better postoperative outcomes. Abdominal route includes both conventional and minilaparotomy; laparoscopic route includes both Laparoscopic Assisted Vaginal Hysterectomy (LAVH) as well as Total Laparoscopic Hysterectomy (TLH). Each method has its own advantages and disadvantages. The vaginal route is preferable because it is associated with less perioperative morbidity and faster recovery. Although laparoscopic route offers minimally invasive alternative to abdominal hysterectomy when vaginal route is contraindicated (In case of huge fibroid uterus or patients with pelvic pathology), it has its own drawbacks. The laparoscopic instruments are costly, there is a long learning curve involved in the training, and the operating time with this route is prolonged.
The EVALUATE study suggested that majority of surgeons(67%) preferred abdominal approach as the route of surgery, especially when dealing with pelvic pathology. Hence, minilaparotomy hysterectomy as an alternative minimally invasive surgery method was started. It relies on traditional open techniques and inexpensive instrumentation, making it significantly faster than laparoscopy and easy to perform. Hoffman et al found minilaparotomy hysterectomy procedure effective and safe in non-obese women in whom vaginal approach was contraindicated. Fanfani et al did a retrospective analysis on 252 patients who underwent minilaparotomy hysterectomy and found it to be a feasible route of surgery in benign gynaecological conditions with operative time similar or shorter as compared to vaginal, laparotomy and laparoscopy surgery. Few surgeons have modified the incision depending on the their experience which led to development of Pelosi method of Minilaparotomy Hysterectomy in 2003.
The final choice of the route and method depends on multiple factors which include indication of surgery, size of fibroid, equipments available in the surgical set up, surgeons' expertise, patient's financial background.
All patients followed the same standard pre-operative protocol. All surgeries were performed under general anesthesia with endotracheal intubation. Demographic details that included age, parity, body mass index (BMI), baseline investigations, diagnosis, and co-morbidities, were collated a day prior to the day of surgery. On admission, patients were informed in detail about the operation modalities and the associated complications. Patients along with their relatives were counselled about the advantages and disadvantages of both the surgical methods and the final decision was made on a joint consensus between the surgeon and the patient, following which an informed written consent was obtained.
The aim of the study was to compare the feasibility of two minimally invasive surgical procedures in low resource settings (such as India) - Laparoscopic assisted vaginal hysterectomy (LAVH) and Minilaparotomy hysterectomy (transverse suprapubic incision <7cm).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MLH | – | –Minilaparotomy Hysterectomy |
| LAVH | – | –Laparoscopic Assisted Vaginal Hysterectomy |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- Women who are admitted in the Department of OBG, Kasturba Hospital, Manipal for hysterectomy for benign gynaecological disorders with non descent uterus.
Key inclusion criteria (1 listed)
- Non descent uterus with benign gynaecological conditions
Key exclusion criteria (8 listed)
- Uterine size > 20 weeks
- Minilaparotomy was contraindicated in patients where severe adhesions might exist eg -
- Patients with one or more contraindications for LAVH were excluded -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Duration of surgery
Time frame: Intra operatively
All surgeries were performed by two gynecologists with an almost equal level of surgical competence.
Blood loss
Time frame: Intra operatively
Total amount of blood loss was calculated during both the methods. It was calculated by adding up the mop count (one fully soaked mop ~ 50 ml of blood loss) and the amount of fluid in the suction pump minus the saline used for irrigation.
Postoperative pain
Time frame: Starting from immediate post-operative period till 72 hours.
There are various methods to score pain. In our study, we used visual analogue scale for the scoring. The pain was scored every 6th hourly for the first 24hrs and thereafter 24th hourly till 72 hrs. The Visual Analogue Scale (VAS) (Figure 14) is a scoring scale on which the patient rates his/her pain on a scale of 0 to 10, 0 representing no pain and 10 representing excruciating or intolerable pain. The scoring is subjective and gives the patient freedom to choose the intensity of the pain as per their perception.
5 secondary outcomes
Weight of uterus
Time frame: Intra operatively
Intra-operative complications
Time frame: Intra-operatively
Conversion rate
Time frame: Intraoperatively
Post operative complications
Time frame: Upto 1 month
Duration of hospital stay
Time frame: Upto 1 month
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 7 Jun 2018.
- Background: PubMed 17978124Wu JM, Wechter ME, Geller EJ, Nguyen TV, Visco AG. Hysterectomy rates in the United States, 2003. Obstet Gynecol. 2007 Nov;110(5):1091-5. doi: 10.1097/01.AOG.0000285997.38553.4b.
- Background: PubMed 15215018Garry R, Fountain J, Brown J, Manca A, Mason S, Sculpher M, Napp V, Bridgman S, Gray J, Lilford R. EVALUATE hysterectomy trial: a multicentre randomised trial comparing abdominal, vaginal and laparoscopic methods of hysterectomy. Health Technol Assess. 2004 Jun;8(26):1-154. doi: 10.3310/hta8260.
- Background: PubMed 9731832Hoffman MS, Lynch CM. Minilaparotomy hysterectomy. Am J Obstet Gynecol. 1998 Aug;179(2):316-20. doi: 10.1016/s0002-9378(98)70358-8.
- Background: PubMed 15808386Fanfani F, Fagotti A, Longo R, Marana E, Mancuso S, Scambia G. Minilaparotomy in the management of benign gynecologic disease. Eur J Obstet Gynecol Reprod Biol. 2005 Apr 1;119(2):232-6. doi: 10.1016/j.ejogrb.2004.07.040.
- Background: PubMed 15744686Pelosi MA 2nd, Pelosi MA 3rd. Pelosi minilaparotomy hysterectomy: a non-endoscopic minimally invasive alternative to laparoscopy and laparotomy. Surg Technol Int. 2004;13:157-67.
- Derived from this study: PubMed 30154857Agarwal A, Shetty J, Pandey D, Jain G. Feasibility and Compatibility of Minilaparotomy Hysterectomy in a Low-Resource Setting. Obstet Gynecol Int. 2018 Aug 1;2018:8354272. doi: 10.1155/2018/8354272. eCollection 2018.
- Individual participant dataSharing planned: Undecided. All IPD that underlie results in a publication maybe shared after sponsor approval. Present status - undecided.
Related trials for Hysterectomy
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Not yet recruiting
COMPARISON OF THE POSTOPERATIVE ANALGESIC EFFECTS OF ULTRASOUND-GUIDED QUADRO-ILIAC PLANE AND TRANSVERSUS ABDOMINIS PLANE BLOCKS IN PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY
Postoperative Pain Following Total Laparoscopic Hysterectomy
Active, not recruitingPhase 2
Intravenous Ibuprofen Postoperative Analgesia After Abdominal Hysterectomy
Post Operative Analgesia
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy
Active, not recruiting
Clinical Assessment - HominisTM Surgical System
Hysterectomy
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.
Abhilasha Agarwal, MS principal investigator
Manipal University
Questions about this trial
What is this clinical trial studying?
An observational study of Hysterectomy and Minimal Invasive Surgery, run by Manipal University.
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 1 inclusion and 8 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 7 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Duration of surgery (time frame: Intra operatively). The study lists 3 primary outcomes in all. 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 NCT03548831, which also lists 6 linked publications.
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 7 Jun 2018.