Laparoscopic techniques for hysterectomy (interventional procedures consultation)

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional Procedure Consultation Document

Laparoscopic techniques for hysterectomy

Hysterectomy is the surgical removal of the uterus. This may be used to treat women with various conditions including chronic pelvic pain, heavy periods, fibroids, or cancer of the uterus or the ovaries. Conventional hysterectomy is performed through an incision in the abdomen or through the vagina. In laparoscopic techniques for hysterectomy, special surgical instruments are inserted through small incisions made in the abdomen, and the operation is carried out with the aid of an internal telescope and camera system. This is sometimes described as 'keyhole surgery'. Part of the operation may also be performed vaginally.

The National Institute for Health and Clinical Excellence is examining laparoscopic techniques for hysterectomy and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about laparoscopic techniques for hysterectomy.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

comments on the preliminary recommendations
the identification of factual inaccuracies
additional relevant evidence.

Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that the Institute will follow after the consultation period ends is as follows.

The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

For further details, see the Interventional Procedures Programme manual, which is available from the Institute's website (www.nice.org.uk/ipprogrammemanual).

Closing date for comments: 24 July 2007
Target date for publication of guidance: November 2007

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.

1	Provisional recommendations

1.1	Current evidence on the safety and efficacy of laparoscopic techniques for hysterectomy (including laparoscopic-assisted vaginal hysterectomy, laparoscopic hysterectomy, laparoscopic supracervical hysterectomy and total laparoscopic hysterectomy) appears adequate to support their use, provided that normal arrangements are in place for consent, audit and clinical governance.
1.2	Clinicians should advise women that there is a relatively higher risk of urinary tract injury and of severe bleeding associated with these procedures, in comparison with open surgery.
1.3	Advanced laparoscopic skills are required for these procedures, and clinicians should undergo special training and mentorship. The Royal College of Obstetricians and Gynaecologists has developed an Advanced Training Skills Module, 'Benign Gynaecological Surgery: Laparoscopy' (http://www.rcog.org.uk/index.asp?PageID=1951). This would need to be supplemented by further training in order to achieve the skills required for total laparoscopic hysterectomy.

The procedure

2.1

Indications

2.1.1

Hysterectomy is performed for a variety of benign conditions that have not responded to conservative management, including heavy menstrual bleeding, symptomatic uterine fibroids, chronic pelvic pain and uterine prolapse. Hysterectomy is also performed for cancer of the uterus (including cervical cancer) and the ovaries.

2.1.2

A conventional 'open' hysterectomy involves removal of the uterus through an abdominal or a vaginal approach.

2.2

Outline of the procedure

2.2.1

This guidance does not cover laparoscopic radical hysterectomy (see 3.1 below). Under general anaesthesia, small incisions are made in the abdomen to allow insertion of a laparoscope and surgical instruments.

2.2.2

In total laparoscopic hysterectomy (TLH) and laparoscopic supracervical hysterectomy (LSH), the entire procedure is performed laparoscopically, including division of the uterine vessels. In TLH the cervix is removed, while in LSH it is left in situ.

2.2.3

In laparoscopically-assisted vaginal hysterectomy (LAVH) and laparoscopic hysterectomy (LH), part of the operation is performed laparoscopically and part vaginally. Uterine vessel division is performed vaginally in LAVH and laparoscopically in LH.

2.2.4

In all of the above procedures, the uterus can be removed either through the open vault of the vagina or one of the abdominal ports.

2.3

Efficacy

2.3.1

A systematic review and meta-analysis reported that in nine randomised controlled trials (RCTs) including 948 women and comparing laparoscopic hysterectomy techniques (type not specified) with abdominal hysterectomy (AH), the average length of hospital stay was 2.0 days (95% CI 1.9 to 2.2) shorter in the laparoscopic group.

2.3.2

The systematic review and meta-analysis reported that in six RCTs including 520 women and comparing laparoscopic techniques for hysterectomy (type not specified) with AH, women in the laparoscopic group returned to normal activities on average 13.6 days earlier (95% CI 11.8 to 15.4) than those in the AH group.

2.3.3

The systematic review and meta-analysis found that in four RCTs including 293 women and comparing laparoscopic techniques for hysterectomy (type not specified) with other vaginal hysterectomy (VH), laparoscopic operations took 41.5 minutes longer to perform (95% CI 33.7 to 49.4). In 10 RCTs including 988 women and comparing laparoscopic techniques for hysterectomy (type not specified) with AH, laparoscopic approaches took 10.6 minutes longer to perform (95% CI 7.4 to 13.8). In 4 RCTs of 466 women comparing LAVH with AH, operating time for LAVH was 7.6 minutes shorter (95% CI 3.0 to 12.2). In the case series of 1692 women who underwent LSH, mean operating time decreased from 159 minutes in the first year of the study to 81 minutes in the sixth year (significance not reported).

2.3.4

The systematic review and meta-analysis reported that in six RCTs including 842 women and comparing laparoscopic techniques (type not specified) with VH, there was no significant difference between the techniques in the need for unintended laparotomy (6 RCTS, n = 842, odds ratio [OR]: 1.55; 95% confidence interval [CI]: 0.75 to 3.21). In a non-randomised controlled study, conversion to laparotomy was required in 7% (82/1242) of women who underwent laparoscopic procedures.

2.3.5

A case series of women undergoing LSH reported conversion to laparotomy in 0.83% (14/1692) of women who underwent TLH. Another case series reported conversion to laparotomy in 2.79% (46/1647). For more details, refer to the sources of evidence (see appendix).

2.3.6

One Specialist Adviser considered laparoscopic techniques for hysterectomy to be established practice and another considered them to be novel and of uncertain efficacy and safety.

2.4

Safety

2.4.1

In a non-randomised controlled study of 37,048 women undergoing hysterectomy, 0/1154 of those treated with laparoscopic hysterectomy techniques (type not specified) died, but 14 undergoing non-laparoscopic techniques died within 6 weeks of the surgery (0.04%, 95% CI 0.025 to 0.064). None of the women who died had undergone a laparoscopic procedure. A non-randomised controlled study of 10,110 women reported that 0.04% (1/2434) of those who underwent laparoscopic procedures (type not specified) died during the convalescence period (not otherwise defined), compared with 0.06% (1/1801) of women who had VH and 0.02% (1/5875) of women who had AH (significance level not stated). The authors stated that the causes of death were alcoholic cirrhosis, cardiac infarct and pulmonary embolism, and were not directly related to the operation.

2.4.2

The non-randomised controlled study of 37,048 women reported that the incidence of major operative haemorrhage was significantly higher (p < 0.001) for laparoscopic techniques (4.4%, 51/1154) than for VH (2.0%, 218/11,122) or AH (2.3%, 571/24,772). However, the non-randomised controlled study of 10,110 women reported no significant difference in perioperative haemorrhage between laparoscopic techniques, VH and AH.

2.4.3

The case series of women undergoing LH reported haemorrhage requiring blood transfusion in 0.3% (5/1648). A case series of women undergoing TLH reported that blood transfusion was required for 0.97% (16/1647).

2.4.4

The systematic review and meta-analysis and the non-randomised controlled study of 10,110 women found that the incidence of urinary tract injuries was significantly higher among women who underwent laparoscopic techniques (type not specified) than those who had AH (OR from meta-analysis 2.61, 95% CI 1.22 to 5.60, 10 RCTs, n = 1912; non-randomised study 1.1% vs 0.2% for ureteric injury and 1.3% vs 0.5% for bladder injury, p < 0.0001). There was no significant difference in the incidence of bowel injury between laparoscopic techniques and AH in either study (meta-analysis: 2 RCTs, n = 1066; non-randomised study, n = 8309).

2.4.5

Comparing laparoscopic techniques with VH, the meta-analysis found no significant difference for urinary tract injury (six RCTs, 805 women), bowel injury (one RCT, 504 women), or vascular injury (four RCTs, 685 women). Comparing laparoscopic techniques with VH, the non-randomised controlled study reported a higher incidence of injuries to the ureter in the laparoscopic group (1.1% vs 0%) and bladder (1.3% vs 0.2%) (p value not stated for either outcome), but a similar incidence of bowel injury (0.4% vs 0.5%) in the two groups (absolute numbers not provided).

2.4.6

There was no significant difference between laparoscopic techniques and AH for vascular injury (2 RCTs, 956 women, OR 1.76, 95% CI 0.52 to 5.87).

2.4.7

A non-randomised controlled study reported that the incidence of visceral damage was higher in women who underwent laparoscopic procedures (1.1%, 13/1154) compared with those who had VH (0.6%, 68/11,122) or AH (0.76%, 189/24,772), but the difference was not significant.

2.4.8

A case series of 5104 women who underwent laparoscopic techniques (type not specified) reported ureter injury in 66 women (3%), simple bladder injury in 22 (0.4%), vesicovaginal fistula in 12 (0.2%), intestinal injury in 15 (0.3%) and major vascular injury in 1 (0.02%). For more details, refer to the sources of evidence (see appendix).

2.4.9

Both Specialist Advisers considered special training to be necessary and to have important implications for safety. They considered theoretical adverse events to be injury to the ureter and bowel, vascular injury, haemorrhage and the need for blood transfusion.

Further information

3.1

The Institute has issued a number of pieces of interventional procedures guidance for procedures with the same indications. These include laparoscopic radical hysterectomy for early stage cervical cancer (www.nice.org.uk/guidance/IPG24), laparoscopic laser myomectomy (www.nice.org.uk/guidance/IPG23), magnetic resonance image-guided percutaneous laser ablation of uterine fibroids (www.nice.org.uk/guidance/IPG30), uterine artery embolisation for fibroids (www.nice.org.uk/guidance/IPG94), impedance-controlled endometrial ablation for menorrhagia (www.nice.org.uk/guidance/IPG104), endometrial cryotherapy for menorrhagia (www.nice.org.uk/guidance/IPG157), laparoscopic helium plasma coagulation for the treatment of endometriosis (www.nice.org.uk/guidance/IPG171), and microwave (www.nice.org.uk/guidance/IPG7), balloon thermal (www.nice.org.uk/guidance/IPG6), photodynamic (www.nice.org.uk/guidance/IPG47) and free fluid thermal (www.nice.org.uk/guidance/IPG51) endometrial ablation. The Institute has also issued technology appraisals guidance on fluid-filled thermal balloon and microwave endometrial ablation (www.nice.org.uk/guidance/TA78) and a clinical guideline on heavy menstrual bleeding (www.nice.org.uk/guidance/CG44).

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
June 2007

Appendix:

Sources of evidence

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

'Interventional procedure overview of laparoscopic techniques for hysterectomy', December 2006

Available from: www.nice.org.uk/ip055overview.

This page was last updated: 30 March 2010