A Trial of Non-absorbable Versus Absorbable Sutures for Trichiasis Surgery

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Brief Title

A Trial of Non-absorbable Versus Absorbable Sutures for Trichiasis Surgery

Official Title

A Randomised Controlled Trial of Non-absorbable (Silk) Sutures Verses Absorbable (Vicryl) Sutures During the Surgical Treatment of Trachomatous Trichiasis

Brief Summary

      Trachoma is the leading infectious cause of blindness worldwide. Recurrent infection by
      Chlamydia trachomatis causes in-turning of the eyelids / lashes (trichiasis), leading to
      corneal damage and blindness. The WHO recommends corrective eyelid surgery for trichiasis.
      Unfortunately, trichiasis frequently returns following surgery. The purpose of this study is
      to compare the outcome of surgery (at one and two years) for trichiasis using two currently
      used alternative suture types: non-absorbable (silk) and absorbable (vicryl). We, the
      researchers, hypothesise that the supportive presence of the absorbable suture for a longer
      period produces more stable wound healing, leading to a better outcome.
    

Detailed Description

      Primary outcome measure:

      Recurrent trichiasis, defined as one or more eyelashes touching the globe or evidence of
      epilation (lash stubs) on examination, or a history of repeat trichiasis surgery since the
      baseline surgery, at one year.

      Justification of primary outcome:

      The aim of surgery is a permanent solution for trichiasis. If a patient has eyelashes
      touching the eyeball or there is clinical evidence that they are epilating to prevent this or
      they have required repeat trichiasis surgery, surgery can be deemed a failure.

      Analysis of primary outcome measure

      Intention to treat analysis of risk factors for recurrence.

      Primary analysis of primary outcome:

      It is expected that the important baseline characteristics (those that are known to affect
      the risk of recurrence) will be balanced between the two arms by stratified (for operating
      surgeon) randomisation. If this is found to be the case, the outcome of the surgery in the
      two arms will be compared in an unadjusted logistic regression model for recurrent trichiasis
      at one year. If the arms are found to be substantially imbalanced with respect to,
      pre-operative severity, gender or age, an appropriately adjusted logistic regression model
      will be used.

      Individuals will be considered to be recurrent trichiasis cases if they have developed
      recurrent trichiasis at anytime during the one year follow-up period.

      Secondary analysis of primary outcome:

        1. Effect modification We will assess effect modification of the intervention on recurrence
           at one year with the following factors by including an interaction term with treatment
           arm in the logistic regression model.

             1. Operating surgeon

             2. Pre-operative severity

             3. Sex

             4. Age group

             5. Conjunctival (papillary) inflammation

             6. Surgical complications

        2. Analysis of risk factors for recurrence:

           A multivariate logistic regression model will be used to identify potential explanatory
           factors for recurrent trichiasis at one year, in addition to the randomised suture type
           allocation. Other factors which will be examined in a model of recurrent trichiasis will
           include

             1. pre-operative disease severity

                  -  trichiasis

                  -  entropion

                  -  corneal opacity

             2. surgeon

             3. infection status at baseline and follow up timepoints

             4. inflammation status at baseline and follow up timepoints

             5. whether epilation is being practised

             6. sex

             7. age

             8. geographic location of patient's home

             9. literacy

            10. body mass index

            11. eye dryness

                  -  symptoms

                  -  signs

        3. Impact of intervention on time-to-first-recurrence. Kaplan-Meier analysis will be used
           to plot the survival curves for both treatment arms up to the final visit at 2 years.
           Cox regression will be used to assess the impact of the intervention on time to first
           recurrence. The hazard ratio will be estimated with Cox regression, adjusting for
           substantial baseline imbalances if appropriate.

        4. Recurrence at two years Intention-to-treat analysis will be used to assess the impact of
           the intervention on failure at 2 years. Failure will be defined as one or more eyelashes
           touching the globe or evidence of epilation (lash stubs) on examination, or a history of
           repeat trichiasis surgery since the baseline surgery, at either one year and/or two year
           follow-up visits.

      Secondary outcome measures

        1. Lashes touching the eyeball The effect of the intervention on the number of lashes
           touching at one, and two years, respectively, will be analysed using zero inflated
           Poisson regression (i.e. treating number of lashes as a continuous variable)

        2. Entropion grade The effect of the intervention on the degree of entropion will be
           analysed by ordered logistic regression

        3. Conjunctivilisation of the lid margin grade The effect of the intervention on the degree
           of conjunctivilisation will be analysed by ordered logistic regression

        4. Clinical evidence of epilation The effect of the intervention on clinical evidence of
           epilation will be assessed at one and two years respectively with logistic regression.
           In addition, Cox regression will be used to analyse time-to-first evidence of epilation.

        5. Repeat surgery The effect of the intervention on the proportion with repeat surgery will
           be assessed at one and two years respectively with logistic regression. In addition, Cox
           regression will be used to analyse time-to-first evidence of first repeat surgery.

        6. Recurrence (lashes touching the eyeball, clinical evidence of epilation, repeat surgery)
           + history of epilation A secondary definition of recurrence will incorporate
           self-reported history of epilation. The primary analyses will be repeated with this
           definition of recurrence.

        7. Corneal opacification (CO) (categorical variable)

             1. Descriptive measures of the baseline severity of CO

             2. Description of the change in CO between baseline and one and two year follow up
                time-points.

             3. Ordered logistic regression analysis for factors associated with change in CO at
                one year and two years, respectively, including to identify factors associated with
                it, such as suture type and inflammation.

        8. Visual acuity (VA) (categorical variable) The effect of the intervention on the visual
           acuity (logMAR score) at 12 and 24 months will be analysed by linear regression.

        9. Surgical complications

           Surgical complications other than recurrence, such as granuloma, incomplete lid closure,
           inflammation (secondary to either of the two sutures materials) and infection can occur.
           Descriptive statistics, with significance testing will be used to compare the rates of
           occurrence of all complications and individual complications at any time during the
           study period between the two arms of the study.

       10. Patient satisfaction

      Patients are asked the following questions on the follow up questionnaires that indicate
      their satisfaction with the procedure:

        1. Do you think your vision is worse, the same or better than before your surgery?

        2. Do you have eye pain?

        3. If you have eye pain is it worse, the same or better than before the operation?

        4. Do your eyes water?

        5. Did you find the surgery painful?

        6. If the eyelashes have returned or will return would you seek further surgery?

      The proportion answering 'yes' to each of these questions will be compared between the two
      arms of the trial.

      Additionally the answers to questions (b) and (d) will be compared between baseline
      (pre-operative) and the answer given at each time point within each arm.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Recurrent trichiasis

Secondary Outcome

 Entropion

Condition

Trachomatous Trichiasis

Intervention

Trichiasis surgery with absorbable sutures

Study Arms / Comparison Groups

 Vicryl Suture
Description:  Vicryl sutures, 5/0, 3/8 curved cutting needle

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

1300

Start Date

March 2008

Completion Date

May 2010

Primary Completion Date

May 2010

Eligibility Criteria

        Inclusion Criteria:

          -  Major trichiasis: more than 5 lashes touching the eye

        Exclusion Criteria:

          -  Previous eyelid surgery
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Matthew J Burton, PhD FRCOphth, , 

Location Countries

Ethiopia

Location Countries

Ethiopia

Administrative Informations


NCT ID

NCT00522860

Organization ID

5025


Responsible Party

Sponsor

Study Sponsor

London School of Hygiene and Tropical Medicine


Study Sponsor

Matthew J Burton, PhD FRCOphth, Principal Investigator, London School of Hygiene and Tropical Medicine


Verification Date

January 2012